Worldwide distribution including US nationwide, Puerto Rico, Australia, Austria, Belgium, Bermuda, CANADA, Denmark, Egypt, ENGLAND, France, Germany, India, Ireland, Hong Kong, Korea, Kuwait, Italy, Malta, Netherlands, Portugal, Qatar, Saudi Arabia, SCOTLAND, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, and UK.
GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x   Picture Archiving and Communication System    Used as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. Also used as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print and export images when connected with the Centricity PACS infrastructure.
While merging exams in a test instance, merges carry forward in the production system, when the middle tier is configured to the wrong IP address of the Centricity Exam Manager.   When a current and historical exam are opened at the same time, the system asynchronously tries to access the operation specifying how each image should be grouped, causing random image-series grouping errors.
Centricity PACS versions 3.1.1.x through 3.2.1.x
*** US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY), District of Columbia, Puerto Rico; *** FOREIGN: Australia, Canada, Costa Rica, Singapore, South Africa
67,410,861 liners and 67,410,861 lids/canisters in total
Hospira has become aware of customers using the incorrect size Receptal liners with their Receptal canisters, e.g., 1.5 L liner, 2L liner or 3L liner with a 1L canister. It is possible that if an incorrectly sized liner is used with a different size canister the lid may not fit and the vacuum/suction will not be sufficient and/or consistent.
Hospira RECEPTAL CANISTERS: 1L(1000mL), 1.5L(1500mL), 2L(2000mL)  Canister, ATS, 2000, with Valve     1) List Numbers 43449-01 and 43449-11; LIST NO. 43449 RECEPTAL CANISTER; CANISTER FOR REUSE, THROW AWAY LINER ONLY; DO NOT FILL 900 ABOVE LINE  2) List Numbers 43423-01 and 43423-21; LIST NO. 43423; RECEPTAL CANISTER; CANISTER FOR REUSE; THROW AWAY LINER ONLY; 1400.   3) List Numbers 43445-01 and 43445-11; LIST NO. 43445; RECEPTAL CANISTER; CANISTER FOR REUSE; THROW AWAY LINER ONLY; DO NOT FILL 1900 ABOVE THIS LINE.  4) List Number 43496-01.
Merck Salix (furosemide 5% injection   50ml   Made in Germany by: Intervet International GmbH Distributed by: Intervet Inc (d/b/a Merck Animal Health) Madison, NJ 07940 www.merck-animal-health-usa.com  UPC 021784-46150-4  NDC 57926-465-01   amber glass bottle, type 1
An incorrect expiry was assigned to one batch of Salix 5%.
Cyclosporine 1%, 10 ml;  store at room temperature
Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Cyclosporine 2%, 15 ml;  store at room temperature
prednisolone acetate, 25 mg/ml, 40 ml unit size;  store at room temperature
Stafac 50 Type A Medicated Articles  NDC# 66104-8815  Packed in a 50 lb/bag (22.6 kg/bag) Multi-wall bag, with the following  construction/configuration: 4 ply Natural Kraft and 1 ply of HDPE 2.0 mil.
Lot R40430001VA Expiration Date: 02/28/2016 (February 28, 2016)
Western Gold 14% Horse Pellet packaged in bags, Net Weight 50 lbs (22.68 kg).  The responsible firm name on the label is Kassik Milling Co., Milligan, NE.
Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) .  FOREIGN CONSIGNEES:  Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.
1, 648,273 devices (all products subject to this recall)
Pouches may not have been sealed during packing.
Temporary Healing Retention Cylinder  Dental implants
1,648,273 devices (all products subject to this recall)
Certain Straight Healing Abutment 4.1mm(D) x 4.1mm(P) x 4mm(H)  Item:ISHA44  Dental implants
1,648,273 (all products subject to these recall)
Conical EP Pick-Up Coping (Hexed)   Dental implants
O-Ring Abutment 4.1mm(D) x 4mm(H)  Item: OSO40  Dental implants
Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 4mm(H)  Item: IWTH54  Dental implants
Preformance Temporary Cylinder  Dental implants
Item: MPFTC34, MPTC32, PFTC41, PFTC42, WPFTC51, WPFTC52, WPFTC61 and WPFTC62.
O-Ring Abutment 4.1mm(D) x 6mm(H)  Item: OSO60  Dental implants
Certain Conical  Abutment  Dental implants
1,648,273 devices  (all products subject to this recall)
Items:  IMCA31, IMCA32, IMCA33, IMCA34, ICA001, ICA002, ICA003, ICA004, IWCA51, IWCA52, IWCA53, IWCA54 and IWCA55.
Implant EP Pick-Up Coping  Dental implants
Items:  IIC60, IIC75, WIP55, WIP56, WIP57, WIP66 and WIP67
Certain Standard Abutment  Dental implants
Items:  IAB200, IAB300, IAB400, IAB550 and IAB700.
Certain Gingihue 15 degree Pre- Angled Post  Dental implants
Implant EP Twist Lock TM Coping  Dental implants
Items:  IIC46, IIC47, WIT56, WIT57, WIT55, WIT66 and WIT67
Certain Gingihue TM 15 degree Angled Post   Dental implants
Conical  Abutment Gold Standard ZR TM  Dental implants
Items:  SCA001, SCA002, SCA003, SCA004, SCA055, SWCA51, SWCA52, SWCA53, SWCA54 and SWCA55.
Certain Gingihue Post 5mm(D) x 5mm(P) x 2mm(H)  Item: IWPP552G  Dental implants
Certain EP Twist Lock TM Coping  Dental implants
1,648,273 devices (all products subject to this recall).
Conical EP Pick-Up Coping (Non-Hexed)   Dental implants
Conical EP Twist Lock TM Coping    Dental implants
Certain Micromini Flat Implant Cover Screw  Dental implants
DAL-RO Housing, Female Assembly  Dental implants
1,648,273devices (all products subject to this recall)
Implant Twist Lock TM Coping  Dental implants
IOL Pick-Up Impression Coping  Dental implants
Certain EP Healing Abutment 4.1mm(D) x 5mm(P) x 2mm(H)    Item: ITHA52  Dental implants
1,648,273 devices (all products subject to this recall.
Items:  MLOA001, MLOA002, MLOA003, MLOA004, MLOA005, MLOA006, LOA001, LOA002, LOA003, LOA004, LOA005 and LOA006.
Standard Abutment Transfer Coping  Dental implants
Certain Implant EP Twist Lock TM Coping   Dental implants
O-Ring Abutment 4.1mm(D) x 2mm(H)  Item: OSO20  Dental implants
Certain Straight Pick Up Coping  Dental implants
Certain Implant Cover Screw  Dental implants
Gold-Tite Hexed Retaining Screw 3mm   Item: GSH30  Dental implants
Conical  Abutment Pick-up Coping  Dental implants
LDA Screw SBL 3mm(D)   Item: SCRSBL1  Dental implants
Certain Temporary Non-Hexed Cylinder  Dental implants
Certain Straight Healing Abutment  Dental implants
Items:  ISMHA32, ISMHA33, ISMHA34, ISMHA36, ISHA46, ISHA48, ISWHA52, ISWHA53, ISWHA54, ISWHA56, ISWHA58, ISWHA62, ISWHA63, ISWHA64, ISWHA66 and ISWHA68.
IOL Transfer Impression Coping  Dental implants
Titanium Hexed Uniscrew  Dental implants
Certain EP Pick-Up Coping  Dental implants
Temporary Hexed Cylinder  Dental implants
Item:  MMTCS1, ITCS41, WTCS51 and WTCS61.
Certain EP Healing Abutment 5mm(D) x 6mm(P) x 4mm(H)  Item: IWTH564  Dental implants
Gingihue 15 Degree Pre-Angled Post  Dental implants
Items: MPAP32G, MPAP34G, PAP454G, PAP462G, PAP464G, PAP472G, PAP474G, PAP552G, PAP554G, PAP562G, PAP564G, PAP572G, PAP574G, PAP662G, PAP664G, PAP672G and PAP674G.
Locator Replacement Housing  Dental implants
Conical 17 degree Angled Abutment  Dental implants
Certain Twist Lock TM Straight Transfer Coping  Dental implants
Item: MPFP34, MPFP36, PFP454, PFP456, WPFP554, WPFP556 and WPFP666.
Certain Pick-Up Coping 4.1mm(D) x 4.1mm(P)  Item: IIIC41  Dental implants
Items:  IMIC33, IIIC60, IIIC75, IWIP56, IWIP57, IWIP66 and IWIP67.
Certain Non-Hexed Implant Pick-up Coping  Dental implants
Pick-Up Impression Coping  Dental implants
1,648,273 (all products subject to thIs recall)
Certain Pick-Up Coping 5mm(D) x 5mm(P)  Item:IWIP55  Dental implants
Gold -Tite Hexed Retaining Screw  Dental implants
Locator Light Retention Replacement Males 4pk  Dental implants
Provide Impression Coping  Dental implants
Item:PIC484, PIC485, PIC654, PIC655, PIC484H, PIC485H and PIC654H.
Certain Gingihue 15 degree Angled  Post  Dental implants
Items:  IPAP464G, IPAP472G, IPAP474G, IPAP462G, IPAP554G, IPAP562G,  IPAP564G, IPAP572G, IPAP574G, IPAP662G, IPAP664G, IPAP672G AND IPAP674G.
Certain Locator Abutment  Dental implants
Items: IMLOA001, IMLOA002, IMLOA003, IMLOA004, IMLOA005, IMLOA006, ILOA001, ILOA002, ILOA003, ILOA004, ILOA005, and ILOA006.
Locator Extra Light Retention Males 4pk  Dental implants
Items: THA42, THA43, THA44, THA46 and THA48.
Locator Replacement Housing Kit  Dental implants
Items:  MCA31, MCA33, MCA34, CA001, CA002, CA004, WCA51 and WCA53.
Certain Pick-Up Coping 4.1mm(D) x 5mm(P)  Item: IIIC12  Dental implants
Temporary Non-Hexed Cylinder  Dental implants
LDA Screw SBL 4mm(D)   Item: SCRSBL2  Dental implants
Certain Gingihue Post 4.1mm(D) x 5mm(P) x 4mm(H)  Item: IAPP454G  Dental implants
IOL Titanium Temporary Cylinder  Dental implants
Certain Straight Pick-Up Coping 5.0mm(D) x 0mm(P) Item:IWIP50  Dental implants
Items: MAP32G, MAP34G, APP462G, APP464G, APP472G, APP474G, WPP554G, WPP562G, WPP564G, WPP572G, WPP574G, WPP662G, WPP664G, WPP672G and WPP674G.
Locator Abutment Impression Coping  Dental implants
Certain Hex Try-in Screw (5 pk)   Dental implants
Certain Gingihue 15 degree Angled Post 4.1mm(D) x 5mm(P) x 4mm(H)  Item: IPAP454G.  Dental implants
1,648,273  devices (all products subject to this recall)
Certain Bellatek Encode Healing Abutment  Dental implants
Items:  IEHA343,  IEHA344, IEHA346,  IEHA348, IEHA353, IEHA354, IEHA356, IEHA358, IEHA443, IEHA444, IEHA446, IEHA448, IEHA453, IEHA454, IEHA456, IEHA458, IEHA463, IEHA464, IEHA466, IEHA468, IEHA473, IEHA474, IEHA476, IEHA478, IEHA553, IEHA554, IEHA556, IEHA558, IEHA563, IEHA564, IEHA566, IEHA568, IEHA573, IEHA574, IEHA576. IEHA578, IEHA663, IEHA664, IEHA666, IEHA668, IEHA673, IEHA674, IEHA676 and IEHA678.
Certain Temporary Hexed Cylinder  Dental implants
Items:  IMMTCS1, IITCS41, IWTCS51 and  IWTCS61.
Locator Replacement Males 4pk  Dental implants
Locator Extra Light Angled Replacement Males 4pk  Dental implants
Standard Abutment Temporary Screw   Dental implants
Certain Preformance Post  Dental implants
Items:  IMPFP34, IMPFP36, IMPFP354, IMPFP356, IPFP456, IWPFP554, IWPFP556, IWPFP664 and IWPFP666.
Certain Gingihue TM 15 degree Angled Post 3.4mm(D) x 3.8mm(P) x 2mm(H)  Item: IMPAP32G  Dental implants
Certain Twist Lock TM Coping  Dental implants
Items:  IIIC46, IIIC47,  IWIT55, IWIT56 and IWIT57.
Items:  IMAP352G,  IMAP354G, IAPP462G, IAPP464G, IAPP472G, IAPP474G, IWPP564G, IWPP572G, IWPP574G, IWPP662G, IWPP664G, IWPP672G AND IWPP674G.
Certain Implant Straight Cover Screw  Dental implants
Gingihue 15 degrees Pre-Angled Post 4mm(D) x 5mm(P) x 2mm(H)   Item: PAP452G  Dental implants
Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 2mm(H)  Item: IWTH52  Dental implants
Certain Conical 17 degree Angled Abutment  Dental implants
Certain Conical 25 degree Angled Abutment  Dental implants
Preformance 15 degrees pre-angled post  Dental implants
Item: MPAPF34, MPAPF36, PAPF454, PAPF456, PAPF554, PAPF556 and PAPF666
Certain Provide Abutment  Dental implants
Certain Preformance 15 degrees Pre-Angled Post  Dental implants
Items:  IMPAPF36, IMPAPF354 and IMPAPF356.
Bellatek Encode Healing Abutment  Dental implants
Certain EP Healing Abutment  Dental implants
Items:  IMHA352, IMHA353, IMHA356, ITHA58, ITHA63, ITHA64, ITHA66. ITHA68, ITHA73, ITHA74, ITHA76, ITHA78, IWTH52, IWTH54, IWTH56, IWTH58, IWTH562, IWTH564,  IWTH566, IWTH568, IWTH572, IWTH573, IWTH574, IWTH576, IWTH578, IWTH62, IWTH63, IWTH64, IWTH66, IWTH68, IWTH672, IWTH673, IWTH674, IWTH676 AND IWTH678.
Certain EP Twist Lock TM Coping   Dental implants
Certain Flat Implant Cover Screw  Dental implants
Conical 25 degree Angled Abutment  Dental implants
Standard Abutment Pick -Up Coping  Dental implants
1,648,273 deices (all products subject to this recall)
Gold-Tite Square Uniscrew   Item: UNISG  Dental implants
Certain Gingihue Post 3.4mm(D) x 3.8mm(P) x 2mm(H)  Item: IMAP32G  Dental implants
Certain Titanium Large Hexed Screw  Dental implants
Titanium Square Uniscrew  Dental implants
Item: PPC484, PPC485, PPC654 and PPC655.
Locator Extended Range Males 4pk    Dental implants
Certain Preformance Temporary Cylinder  Dental implants
Items:  IMPFTC34, IMPFTC32, IPFTC41, IPFTC42, IWPFTC51, IWPFTC52, IWPFTC61 and IWPFTC62.
Recalled product was distributed to 2 states:  Virginia and Massachusetts.
(10.2cm x 7.6 em) was included in a limited number of convenience kits (custom procedure trays) that were not labeled as containing latex.
AZ, CA, CO, GA, IN, KY, LA, MA, MI, NJ, OH, OR, TN, TX, UT, WA, WI, and in CANADA and IRELAND
Yellow ORGANIC Onion Strip, Item number 103356, bulk tote, net wt. 1150 lbs.
Yellow ORGANIC Onion Strip are voluntarily recalled because it has the potential to be contaminated with Listeria monocytogenes.
Yellow Onion Dice, Frozen, item number 101430, bulk tote, net wt. 1200 lbs.
Frozen Yellow Onion Dice is voluntarily recalled because it has the potential to be contaminated with Listeria monocytogenes.
White Onion Dice- FRESH, item number 105197, bulk tote, net wt. 1250 lbs.
White Onion Dice- FRESH is voluntarily recalled because it has the potential to be contaminated with Listeria monocytogenes.
White Onion Strip-FRESH, item number 105196, bulk totes, net wt. 1200 lbs.
White Onion Strip-FRESH was voluntarily recalled because it has the potential to be contaminated with Listeria monocytogenes.
IQF 45#CS, item number 104155, bulk cases, net wt. 45 lbs.
Yellow Onion Dice, item number 101578, bulk container
Frozen Yellow Onion Dice was voluntarily recalled because it has the potential to be contaminated with Listeria monocytogenes.
Un-Blanched Yellow Onion Dice, Frozen, item number 103349, bulk cases, net wt. 45 lbs.
Un-Blanched, Frozen, Yellow Onion Dice is voluntarily recalled because it has the potential to be contaminated with Listeria monocytogenes.
Frozen WHITE Onion Dice, item number 103342, bulk cases, net wt. 45 lbs.
White Onion Dice is voluntarily recalled because it has the potential to be contaminated with Listeria monocytogenes.
IQF 1/4 x 1/4 Yellow Onion Dice, item number 102654, bulk cases, net wt. 40 lbs.    Onion 1/4 x1/4 Dice, Item number 103205, bulk cases, net wt. 45 lbs.
1/4 x 1/4 Frozen Yellow Onion Dice was voluntarily recalled because it has the potential to be contaminated with Listeria monocytogenes.
Product was distributed to CA, IL, and MI. There was no foreign/military/government distribution.
Sun Life Natural Sunflower Spread with Chocolate in clear plastic jar with brown plastic lid, Net Wt. 12 oz.., UPC 855881003370. The responsible name on the label is Nu Life Market, LLC, Scott City, KS.
Product manufactured with roasted sunflower kernels which may be contaminated with Listeria monocytogenes.
Sun Life Natural Sunflower Kernel Paste, Net Wt. 40 lbs (18.18 kg) buckets and 450 lbs. (204.12 kg) barrels.  The responsible name on the label is Nu Life Market, LLC, Scott City, KS.
Sun Life Enjoy Life Sunflower Spread, Net Wt.. 40 lbs (18.18 kg).  The responsible name on the label is Nu Life Market, LLC, Scott City, KS.
Sun Life Natural Sunflower Spread with Maple in clear plastic jar with brown plastic lid, Net Wt. 12 oz.., UPC 855881003370. The responsible name on the label is Nu Life Market, LLC, Scott City, KS.
Sun Life Natural Sunflower Spread in clear plastic jar with brown plastic lid, Net Wt. 12 oz., UPC 855881003370. The responsible name on the label is Nu Life Market, LLC, Scott City, KS.
Arbonne manufactures and/or distributes cosmetic products, including It's A Fine Line Liquid Eye Liner in the US. It's A Fine Line Liquid Eye Liner is sold via the Arbonne website, www.arbonne.com. Independent Consultants who market the Arbonne eye liner product direct consumers to purchase the product online, as well. Arbonne subsidiaries, Arbonne Europe SarL, Arbonne UK Ltd., and Arbonne International Distribution, Inc., have also distributed It's A Fine Line Liquid Eye Liner in Canada, the United Kingdom, Poland, and Australia.    This product was not sold under a government contract and was not sold to any federal, state, or local agency involved in the school lunch program.
Arbor (Brown) Liquid Eyeliner, Catalog SKU#6736, Product Code: 80000073
Arbonne is recalling Eclipse (Black) & Arbor (Brown) liquid eyeliner due to Staphylococcus saprophyticus, Staphylococcus lentus, and Staphylococcus xylosis.
Eclipse (Black) Liquid Eyeliner, Catalog SKU#6735, Product code: 80000072
Directly distributed to TX, further distributed to AL and MS
The manufacturer has identified that the stated Femoral Plateau Plates may not fit into the intended Femoral Knee mating component and thus sit flush upon the Femoral Knee component prior to implantation.
Catalogue Numbers: mkfp/Std5 and mkfp/Std10  Batch Numbers: B4311 and B5470
Worldwide Distribution-US (nationwide) distribution to states of: AZ, CA, CO, DC, FL, IL, MA, MI, NJ, NY, PA, TX, UT, WI, and WV; and countries of: Australia, Canada and Switzerland.
TI Single Vector Distractor Body with Left Foot/30mm; Catalog ID 487.965    The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects.
DePuy Synthes is voluntarily initiating a recall  due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely separated from the Proximal Foot Plate.
TI Single Vector Distractor Body with Right Foot/30mm; Catalog ID 487.964    The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects.
TI Single Vector Distractor Proximal Foot/Right; Catalog ID 487.974    The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects.
TI Single Vector Distractor Body with Right Foot/20mm; Catalog ID 487.962    The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects.
TI Single Vector Distractor Body with Left Foot/20mm; Catalog ID 487.963    The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects.
TI Single Vector Distractor Proximal Foot/Left; Catalog ID 487.975    The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects.
AL, AR, AZ, CO, FL, GA, IA, IL, IN, KS, KY, LA, MI, MN, MO, MS, MT, ND, NE, NM, OH, OK, SD, TN, TX, WI, WV, WY
Nir's Lamb-Stuffed Zucchini with Spiced Lentil Stew
Possible contamination with Listeria monocytogenes
No expiration date or lot numbers are assigned.
Summer Vegetable Salad with Seared Chicken, Garlic Croutons, and Mustard-Chive Vinaigrette
Seared Steak with Spring Veggie Succotash and Mint-Chive Pesto
Lemony Pan-Seared Chicken with Pesto Potato Salad and Peas
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Al Rasheed Sardine Item #4017  Label not available - NYSDAM sampling.
Greenland Trading Corporation is recalling Al Rasheed Sardines due to potential C. botulinum contamination.
Worldwide Distribution - US (Nationwide) Internationally to   Canada, Austria, China, Netherlands, Norway, India, Korea, Germany, France, Switzerland, Ireland, Italy, Singapore, Russia, UK, Malaysia,
LC/MS/MS System. In-Vitro Diagnostic  Instrument Part Number (REF): 5024501  3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass. It is intended for in vitro diagnostic purposes. For in vitro diagnostic use.
MultiQuant MD software where under certain conditions a user  can be presented with incorrect quantitative results when using the Sum Multiple Ions feature.
Software Version:  MultiQuant MD 3.0, MultiQuant MD 3.0.1 and MultiQuant MD 3.0.2 software
AB SCIEX Triple Quad 4500MD LC/MS/MS System.  Mass Spectrometer  for In-Vitro Diagnostic Use.  Instrument Part Number (REF): 5031257  3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass. It is intended for in vitro diagnostic purposes. For in vitro diagnostic use.
US and New Zealand, Australia, Canada, Japan, Israel, United Kingdom, Italy, Mexico.
Perioscopy Sheath:  Part number: 1008;        The Perioscopy Sheath is a single-use sterile component used with the Perioscopy System, which is a medical device that features miniaturized digital video technology, and enables the healthcare professional to see magnified details of the tooth anatomy and deposits below the gum line (i.e. calculus root fractures, restoration margins, tooth decay).
The Perioscopy Sheaths are currently provided with a label that indicates the Sheath has a 3 year shelf-life/expiry date.  Danville Materials has become aware that validation data are not available to support the 3-year shelf-life/expiration dating claim.
ORTHO ProVue Analyzers; Product Code MTS213784; Unique Device Identifier (GTIN) 10758750006014
ORTHO ProVue Analyzers,  with suboptimal reference images and/or  Brillo values outside of specification, were distributed.
Stryker Instruments Div. of Stryker Corporation
Worldwide distribution.  US nationwide, France, Netherlands, Spain, Italy, Canada, Israel, Romania, Switzerland, and United Kingdom.
Stryker AutoPlex System.  Model Numbers  0607-687-000, 0605-887-000, 0605-687-000, and  0605-683-000.  For bone cement.    Stryker AutoPlex System kits contain a cement mixer, cement injector, funnel, and an extension tube assembly whereby bone cement powder and liquid monomer are mixed inside a chamber and transferred into a cement injector automatically. The bone cement is then dispensed directly into a fracture site using the cement injector and introducer needle combination.
The Piston Head can become separated from the Delivery Piston, blocking the injection assembly Valve resulting in a cement backflow towards the injector handle.  Potential for delay in surgery if additional cement needs to be prepared for the injection procedure.
US Nationwide Distribution in the states of: NY, PA. GA. AZ, VA, DE, ME,. MO, TN, and NM.
OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier.    Ophthalmic: The OPTICAL BIOMETER AL-Scan is a measuring device that can measure as a single unit the values necessary to calculate the power of an IOL for cataract surgery such as axial length, corneal curvature radius, and anterior chamber depth. It measures these necessary values successively through a non-contact optical measurement method.
Nidek Inc. received information from our manufacturer NIDEK CO.  Japan that the shown axial  lengths were much shorter at AL-Scan measurement.
Worldwide Distribution - US (nationwide) and Internationally to  Australia, Canada, Japan, Korea, Hong Kong, Thailand,
Valleylab Laparoscopic Wire J-Hook Electrode 28CM	  Item Code: E278228  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
Potential for compromise of the package resulting in a breach of the sterile barrier
Affected Lot Range:  209822X through 61220117X
Valleylab Laparoscopic Flat L-Hook Electrode 36CM	  Item Code: E277436  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
Affected Lot Range:  210652X through 61390114X
Valleylab  Laparoscopic Wire J-Hook Electrode 36CM  Item Code: E277236  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
Affected Lot Range:  210110X through 61250197X
Valleylab Laparoscopic Wire J-Hook Electrode 36CM  Item Code: E277336  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
Affected Lot Range:  00378X through 61220135X
Valleylab Laparoscopic Flat L-Hook Electrode Retractable	  Item Code:  E2784R28ASP  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
Affected Lot Range:  209503X through 60870086X
Valleylab Laparoscopic Curved Spatula Electrode 45CM  Item Code: E277145  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
Affected Lot Range:  209505X through 61220130X
Valleylab Laparoscopic Flat L-Hook Electrode 28cm	  Item Code: E278428  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
Affected Lot Range:  209220X through 52140033X
Valleylab Laparoscopic Cylindrical Tip Electrode 28CM  Item Code:  E278628  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
Affected Lot Range:  213786X through 61220121X
Valleylab Laparoscopic Curved Spatula Electrode 36CM  Item Code: E277136  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
Affected Lot Range:  210654X through 61380120X
Valleylab Laparoscopic Argon Sharp Needle Electrode 28CM  Item Code: E258228  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
Affected Lot Range:  216416X through 60080002X
Item Code: E25306  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
Affected Lot Range:  210286X through 61220102X
Valleylab Laparoscopic Curved Spatula Electrode Retractable 28CM	  Item Code: E2781R28ASP  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
Affected Lot Range:  209358X through 60870083X
Valleylab Laparoscopic Flexible Laparoscopic Argon Blade Electrodes 28CM  Item Code: E258028  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
Affected Lot Range:  210573X through 60870080X
Valleylab Laparoscopic Wire L-Hook Electrode 28CM  Item Code: E278328  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
Affected Lot Range:  209965X through 60870090X
Valleylab Laparoscopic Straight Spatula Electrode 28CM	  Item Code: E278028  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
Affected Lot Range:  212060X through 60520072X
Valleylab Laparoscopic Argon Modified Flat l Electrode 28CM  Item Code: E258128  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
Affected Lot Range:  211742X through 60870082X
Valleylab Laparoscopic Curved Spatula Electrode 28CM	  Item Code: E278128  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
Affected Lot Range:  209716X through 61220115X
Valleylab Laparoscopic AP Argon Blunt Needle Electrode 28cm  Item Code: E258328  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
Affected Lot Range:  210556X through 60520063X
Valleylab Laparoscopic Wire L-Hook Electrode Retractable  Item Code: E2783R28ASP  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
Affected Lot Range:  209284X through 60870084X
Item Code: E25303  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
Valleylab Laparoscopic Wire L-Hook Electrode Retractable	  Item Code: E2783R36ASP  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
Affected Lot Range:  208908X through 61220113X
Valleylab Laparoscopic Wire J-Hook Electrode 45CM	  Item Code: E277345  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
Affected Lot Range:  210409X through 61220133X
Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes  Item Code: E253028  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
Affected Lot Range:  210141X through 61220104X
Valleylab Laparoscopic Wire J-Hook Electrode Retractable 28CM  Item Code: E2782R28ASP  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
Affected Lot Range:  213559X through 60520066X
Valleylab Laparoscopic Straight Spatula Electrode 36C	  Item Code: E277036  The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
Affected Lot Range:  215084X through 61220127X
Haitai Matdongsan Peanuts Crunch Snack, Net Wt. 11.49 oz. (325gr), Imported and Distributed by: Haitai, Inc, 7227 Telegraph Road, Montebello, CA 90640 - H & E Trading Inc, 514 Eugene Way, Wyckoff, NJ 07481, UPC 8 801019606786
Haiati Matdongsan Peanut Crunch Snack, 80g and 325g, plastic flex bag is being recalled because it contains Soy Lecithin and this was not listed on the finished product labeling.
Nationwide including Puerto Rico, and outside the US to include:  Australia, Austria, Finland, Germany, Greece, Ireland, Italy, the Netherlands, Norway, Poland, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, United Kingdom.
Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes:   1 cm x 6 cm, product code VG0106N,   0.8 cm x 8 cm, product code VG0108N,   1 cm x 10 cm, product code VG0110N, and   2 cm x 9 cm, product code VG0209N.    VASC U-GUARD is prepared from bovine pericardium which is cross-linked with glutaraldehyde.  Sterilized using aseptic processing techniques.  The pericardium is procured from cattle originating in the United States.  VASC-Guard is chemically sterilized using ethanol and propylene oxide.
Baxter is issuing a safety alert in response to postmarketing reports received for the VASC U-GUARD Peripheral Vascular Patch.  Baxter has received reports for intraoperative or postoperative bleeding episodes, which required additional clinical intervention.  One report involved a case with a fatal outcome.
Bulk flour bland breader packaged into 15, 30, and 50 lb bags or boxes.
Flour contaminated with E. coli O121 was used in the manufacuring of flour based blends.
Tortilla Crusted Crumb is a breading system. Product Item Key N21997-B.  It composed of flour and other food grade ingredients.  Product is bagged in 25 lbs. multiwalled polylined paper bags.
Tortilla Crusted Crumb is recalled due to a potential to be contaminated with E. coli O121.
Nationwide Distribution to the following; CA, LA, VA, IA, AR, SC, PA, MA, IL, MO.    Foreign distribution to the following; Canada, Belgium, Australia, Taiwan, China, Argentina.
May contain two trocar tip stylets with coaxials or two blunt tip stylets instead of one of each.
Procesadora de Frutos y Vegetales del Caribe
U.S. consignees -     New York, United States.    No U.S. Government Agency consignees    No Foreign consignees     Please note: The firm ceased further distribution of the product(s) on   06/20/2015
Coconut milk , 13.5 fld oz, can, 214x406  3 pieces steel tins ,24 tins per case.  Refrigerate after opening.
Lots involved are 32 ,35, 37,41,43,47,39, 53 and 57. All these lots expire on May of 2018. The UPC code that identifies the P.A Coconut milk is: 7189123232406
TRYX Neuro Absorbable Antibacterial Envelope    Product Usage:  Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
TRYX products are being recalled since the processes of  spaying, welding, drying oven and polymer were not adequately validated.
model number    NMRM6122     lot number    16E03727  16E05728    model number    NMRM6133    lot number    16E02726  16E09730
TRYX Absorbable Antibacterial Envelope    Product Usage:  Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
model number   CMRM6122     lot number  16E03727  16E05728    model number   CMRM6133    lot number   16E02726  16E06729
TRYX Antibacterial Envelope Rx Only    Product Usage:  Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
Nationwide Distribution to CA, CO, IA, KS, MD, MI, NY, NC, PA
Weck EFx Classic Fascial Closure System, Rx Only, Sterile,    The product is intended to facilitate placement and withdrawal of suture loops to repair port side defects following laparoscopic surgery
Incorrect expiration date was printed on the product label.
Product Code EFXCT1 - Lot/Batch Nos. ML-000342, ML-000343, ML-000344, ML-000348, ML-000349; Product Code EFXSP1 - Lot/Batch Nos. ML-000345, ML-000347
FL  IL  KS  MI  MN  MO  NJ  OK  TX  CANADA
SOUTHWEST BREADER G2293  25 LB BAG  POLY BAG  ITEM G2293.43
Kerry Inc. was notified by our supplier that two of their products, a red bell pepper nugget and a jalapeno nugget, were made with a small percentage of affected flour which was recalled by General Mills because it may be contaminated with E. coli O121.
Glipizide 2.5 mg Extended-release tablets, 30-count bottle, Rx Only, Manufactured By: Patheon Pharmaceuticals Inc Cincinnati, OH  45237, NDC 00591-0900-30  NDC 00591-0900-30
Failed dissolution specifications: Glipizide 2.5 mg ER  Tablets exceeded  dissolution specification rates for the 10 hour testing point.
Mindray DS USA, Inc. dba Mindray North America
Mindray DS USA Inc., Passport Series Patient Monitor intended for monitoring, displaying, reviewing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, arrythmia detection, ST segment analysis, and heart rate (HR), Respiration rate.
Mindray has identified a potential leakage issue with the CO2 Module's Dryline II Water Trap used with the Passport Series Patient Monitor.
Distribution was made to medical facilities nationwide and to one foreign medical facility in New Zealand.  There was no military or government distribution.
iConnect Access used with Merge PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks.
146 sites potentially have the affected versions for both products
Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not display the correct current patient demographics if there has been a PDE (Patient / Study Demographic Edit) performed after the images were ingested in PACS.
iConnect Access V4.0 or earlier with any version of Merge PACS and iConnect Access V4.1 with Merge PACS V6.5.4 or earlier
iConnect Access used with Ortho PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks.
146 sites may have the affected version for both products
iConnect Access V4.0 or earlier with any version of Ortho PACS and iConnect Access V4.1 with Ortho PACS V5.1.2 and earlier.
Masks in this lot, labelled and sold as 62702 vented Quattro Air FFM size Medium actually contain a non-vented (NV) Quattro Air FFM Large mask.
District of Columbia; Wisconsin; Switzerland
Blood products, collected from an ineligible donor, were distributed.
Blood and Blood Products for Reprocessing
PROFEMUR(R) MODULAR NECK, HIP FEMORAL NECK MicroPort total hip systems intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
Profemur(R) neck, Item Number PHA01222 (Short AR VV2 Ti Neck) was labeled as Item Item Number PHA01212 (Short AR VV1 Ti Neck).
Venlafaxine HCL ER Capsule USP, 150mg, packaged in a) 30-count bottles (NDC 68382-036-06), b) 90-count bottles (NDC 68382-036-16), and c) 1000-count bottles, (NDC 68382-036-10), Rx only, Manufactured by :  Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534.
Failed Dissolution Specifications: out of specification dissolution results in retained samples
Venlafaxine HCL ER Capsule USP, 75mg, packaged in a) 30-count bottles (NDC 68382-035-06), b) 90-count bottles (NDC 68382-035-16), and c) 1000-count bottles, (NDC 68382-035-10), Rx only, Manufactured by :  Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534.
Domino PURE CANE LARGE GRAIN GRANULATED SUGAR, NET WT 50 LB (22.67 kg), Distributed by Domino Foods, Inc., Yonkers, NY 10705
Product was found to contain metal fragments.
Codes 56131 through 56177 and Codes 56181 through 56207
US: Distribution to the states of :  NY, OH and CA.
ReShape Integrated Dual Balloon System, Gen 1, Catalog No. RSM110, Model No. 01-0013-001    The ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conjunction with diet and exercise, in obese patients with a Body Mass Index (BMI) of 30 40 kg/m2 and one or more obesity related comorbid conditions. It is indicated for use in adult patients who have failed weight reduction with diet and exercise alone.
Due to a suspected misalignment of the connection between the proximal balloon cap of the implant and the delivery catheter.  The possible misalignment is the result of an assembly error during manufacturing and may lead to leakage of saline solution during the balloon inflation procedure.
Medtronic Cardiovascular Surgery-the Heart Valve Division
Worldwide Distribution -- US, Australia, Austria, Belgium, Brazil, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Greece,  Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Kazakhstan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Macedonia, Malaysia, Morocco, Netherlands, New Zealand, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C, and ENVEOR-US.    Designed to replace the native or surgical bioprosthetic aortic heart valve without open heart surgery and without concomitant surgical removal of the failed valve.
Potential for vascular trauma with the use of the Medtronic EnVeo R Delivery Catheter System (DCS).
Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration
US only: PA, DE, FL, SC, ME, CA, IL, NC, TX, WA, NY, TN, FL, OR, OK, MO, MS, GA, NM, IN, OH, MD, VA, CO, AZ, and NC.
Xpert MRSA  Catalog GXMRSA-120, Rev. AJ    Microbiology:    The Cepheid Xpert MRSA assay performed in the GeneXpert Dx System  (Xpert MRSA) is a qualitative in vitro diagnostic test designed for rapid detection of Methicillin-Resistant Staphylococcus Aureus (MRSA) from nasal swabs in patients at risk for nasal colonization
Internal investigation found the certain lots of MRSA kits have the potential for performance issues at lower positive sample concentrations.
Catalog number: GXMRSA-120, Rev. AJ;  Lot numbers: 1000037539 (Cartridge lot 20417) and 1000029307 (Cartridge lot 20419).
Worldwide Distribution - US to VA, WV, GA, TN, KY, MN, SD, AR, OK and Internationally to Canada
VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191 2997, Unique Device Identifier No. 10758750000227, IVD --- Ortho-Clinical Diagnostics Pencoed Bridgend CF35 5PZ UK  For the in vitro quantitative measurement of thyroid stimulating hormone (TSH) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.
A field correction was issued by the firm for VITROS TSH reagent lot 5040 due to a higher than expected frequency of customer calibration curves falling outside of the calibration quality parameters and therefore unusable to process samples.  Customers using VITROS TSH Lot 5040 will potentially experience an unexpected increase in the unsuccessful calibrations potentially causing a delay in testing and reporting results for VITROS TSH.
Distributed to one customer only in US state of Georgia.
OraQuick Ebola Rapid Antigen Test, Product Code  3001-2807;   Intended for the qualitative detection of antigens for Ebola viruses.
Failed stability testing at 8 months.  This lot produced intermittent false negative results for the positive kit control with devices stored at 30C conditions.
Product Code  3001-2807 and the lot number is 6648965. Expiration date October 31, 2016.
US Distribution to states of: CA, PA, TX, and  MT.
Merge Unity Z3D software.    Merge Unity PACS (formerly DR Systems PACS) is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.
9 sites potentially have the affected version
The software is unable to accurately determine the calcium score of scans with a slice thickness not equal to 3 mm.
Venlafaxine Hydrochloride Extended-Release Capsules, 150 mg, a) 30 capsules per bottle, NDC # 60429-123-30, b) 90 capsules per bottle, NDC # 60429-123-90, Rx Only, GSMS.
Failed Dissolution Specifications: Out-of-specification results in retained sample.
Venlafaxine Hydrochloride Extended-Release Capsules, 75 mg,  90 capsules per bottle, Rx Only, GSMS, NDC # 60429-122-90
Xario 100 Diagnostic Ultrasound System, TUS-X100; Xario 200 Diagnostic Ultrasound System, TUS-X200.
Toshiba American Medical Systems (TAMS) is recalling the Xario Diagnostics Ultrasound System because it may become hot because of a software error.
1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile  REF# 1009-00J    Product Usage:  The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves
Wire which deploys the loop may be come detached at the handle causing the device to be inoperable
1.5 mm HYDRO LeMaitre Valvulotome, 98 cm, Sterile   REF # 1009-00    Product Usage:  The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves
1.5 mm HYDRO LeMaitre Valvulotome, 40 cm. Sterile  REF # 1010-00    Product Usage:  The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves