Recalling Firm
Stryker Medical Division of Stryker Corporation
Becton, Dickinson and Company, BD Biosciences
Penrose-St Francis Health Services Blood Bank

Initial Firm Notification of Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Distribution Pattern
Domestic: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KY, KS, LA, MA, MD, MI, MN, MS, MD, MT, NC, NH, NJ, NY, NV, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY, Foreign accounts: Aurba, Canada, Santo Domingo.
Distribution US nationwide, Canada, and Mexico.
US Nationwide Distribution including DC and PR. Internationally Canada.
U.S. distribution nationwide. No foreign distribution.
Products was distributed to the southern midwest and central south including the states of AR, OK, IA, IL, KS, MO, and TX.
Products were sold in the following states: AL, AR, CA, FL, GA, IL, IN, MS, NC, ND, NJ, NV, NY, OH, PA, SC, TN & VA. Products were also shipped to the following countries: Albania, ALGERIA, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Burundi, Cape Verde, Chile, China, Colombia, Congo, Democratic, Costa Rica, Cyprus, Dominican Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Hungary, India, INDONESIA, Ireland, Italy, Japan, Jordan, Latvia, Lebanon, Libyan Arab Jamahiri, Lithuania, Malawi, Mali, Mexico, Morocco, Myanmar, Namibia, Nepal, Netherlands, Nigeria, Oman, Palestine, Paraguay, Philippines, Poland, Romania, Russia, Senegal, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, United Kingdom, Venezuela, Viet Nam & Zambia.
Worldwide Distribution -- USA, U.A.E., Algeria, Armenia, Australia, Austria, Bangladesh, Belgium, Bosnia Herzeg., Botswana, Canada, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Libya, Lithuania, Malaysia, Mexico, Namibia, P.R. China, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., and United Kingdom.
Distributed in the states of CT, IL, MA, MI, NV, NH, NC, and TX, and the country of Canada.
Distributed in the states of FL, PA, NY, MD, CA, and AZ.
Worldwide Distribution - US to CA, CO, CT, FL, GA, IA, ID, IL,IN,KS,KY,LA,MA,MD,MI,MS,MT,NC,NE,NJ,NM,NY,OH,PA,SC, TN,TX,UT,VA,WA and Internationally to Canada, Germany and New Zealand.
US Distribution to the states of : CA, FL, GA, IL, IN, MI, MN, MO, NY, OR, PA, TX, WA, and Internationally to Germany, Italy and Switzerland
Worldwide Distribution - US Nationwide and the countries of: Canada, AUSTRALIA, CHINA, HONG KONG, THAILAND, POLAND, RUSSIAN FEDERATION, SLOVENIA, UNITED ARAB EMIRATES, AUSTRIA, BELGIUM, DENMARK, FINLAND, FRANCE, GERMANY, ICELAND, IRELAND, ISRAEL, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, SPAIN, SWITZERLAND, and UNITED KINGDOM.
Nationwide Distribution to FL, IN, LA, NC, PA, TN and UT
Distributed in the states of CA, FL, GA, IA, IL, IN, KS, KY, MA, MI, NV, NY, OH, PA, TX, and WA.
US Nationwide Distribution in the states of FL, KS and WV.
AZ, CA, IL, IN, MN, OH, PA and WI. Outside the US to include: Canada
Nationwide to PA, TX, TN, NV, VA, WV, and KY. No Canadian, other foreign, VA/gov/military consignees.
US, including Puerto Rico and Australia, Austria, Belgium, Chile, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Japan, Monaco, Netherlands, Norway, Portugal, , Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, Venezuela.
US Distribution to the states of : CA, FL, GA, IA, IL, IN, MD, NC, NY, OH, PA, SD, TN, TX & WY., and Internationally to Brazil and Mexico.
Nationwide Distribution to: AK,AL,AR,AZ,CA,CO,CT,DC,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,PR,RI,SC,SD,TN,TX,UT,VA,WA,WI,WV,WY, Puerto Rico and Guam
US Distribution to states of: AR, CA, CO, DE, FL, GA, IA, IL, KY, LA, MN, NJ, OK, PA, SD, TN, and WA.
Worldwide Distribution: US (nationwide) and countries of: Canada, Mexico, Japan, Netherlands, Algeria, Australia, Brazil, Chile, China, France, Guatemala, Hong Kong, Italy, New Zealand, Pakistan, Philippines, Singapore, Taiwan, and United Kingdom.
US Distribution to the states of : FL, VA, OK, CO, DC and IN.
Worldwide Distribution - US Nationwide in the states of: AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MO, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WV, WI, and the countries of Angola, Argentina, Austria, Australia, Austria, Botswana, Brazil, Burkina Faso, Cambodia, China, Columbia, Djibouti Antilles, Estonia, Georgia, Germany, Greece, India, Israel, Italy, Kuwait, Latvia, Malaysia, Mexico, Netherlands, Poland, Qatar, Russia, Senegal, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, Zambia, and Zimbabwe
Nationwide, Puerto Rico, and foreign distribution to the following countries: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Poland, Singapore, Spain, Venezuela.
The software was distributed to medical facilities nationwide. Government distribution was made to MN. Foreign distribution was made to Australia and to the United Kingdom. There was no military distribution.
Worldwide Distribution -- USA and Australia.
Worldwide Distribution: US (nationwide) and Countries of: Austria, Belgium, Canada, Germany, Denmark, Spain, France, Great Britain, Italy, Netherlands, Norway, Poland, Portugal, Russia, and Turkey.
Nationwide distribution to AR, CA, CO, IL, IN, LA, MA, MD, Ml, MN, NC, NJ, NM, NY, OR, PA, TN, TX, WA

Product Description
Healthwise, Protein Chips, Barbecue Crunch, Net Weight 1.2 ounces (34 grams), Distributed by Nutritional Resources, Inc., Grovetown, GA 30813.
S3 MedSurg Bed, Model 3005. Stryker Medical
Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjustable surface contours.
Brilliance BigBore Radiology Computed Tomography X-ray systems, intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Brilliance CT 16 Power Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Brilliance BigBore Oncology Computed Tomography X-ray systems, intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Ingenuity Core Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Brilliance 16 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Ingenuity Core 128 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Brilliance 64 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Brilliance iCT SP Model No. 728311; To produce cross-sectional images of the body.
Ingenuity Core128 Model No. 728323; To produce cross-sectional images of the body.
Brilliance 64 CT Model 728231; To produce cross-sectional images of the body.
Ingenuity Core Model No. 728321; To produce cross-sectional images of the body.
Ingenuity CT Model No. 728326; To produce cross-sectional images of the body.
Brilliance iCT, Model No. 728306; To produce cross-sectional images of the body.
Cafe Favorites Oven Roasted Turkey Breast Sub Code #C02284/02284
Integrated Food Service Chicken Hot Dog on a Whole Grain Bun Code #941500
Integrated Food Service Turkey Ham & Cheese Sandwich on a Whole Grain Knot Roll Code #130008/C13008
Integrated Food Service Submarine on a French Roll Turkey Bolo, Turkey Salami and Cheese on a Whole Grain French Roll Code #C14001/140001
Integrated Food Service Turkey Bologna & Cheese Sandwich Turkey Bologna on a whole Grain French Roll Code #C12001/120001
Integrated Food Service Chicken Double Dogs on Whole Grain Buns Code #809021
Integrated Food Service Chicken Patty Sandwich Chicken Patty on a Whole Grain Bun Code #400003
Integrated Food Service Egg & Cheese Bagel Thin Sandwich Code #C38004/380004
Integrated Food Service Bean & Cheese Chalupa-Bulk Code #C82705/827005
Integrated Food Service Chili Cheese Dog on Whole Grain Buns Code #809022
Integrated Food Service Beef Sausage Sandwich Beef Sausage Patty on a Whole Grain Hawaiian Bun Code #990018
Cafe Favorites Italian Deli Flatz Code #C22548/22548
Integrated Food Service All America Burger Beef Patty on a Whole Grain Bun Code #470007
Integrated Food Service Turkey Breast Combo on a Whole Grain Knot Roll Code #C15008/150008
Integrated Food Service Turkey Sausage & Cheese Bagel Thin Sandwich Code #809013
Integrated Food Service Chili Cheese Dog Whole Grain Hot Dog Bun, Chicken Frank, Chili Sauce and Reduced Sodium Reduced Fat American Cheese Code #C95150/951500
Integrated Food Service Original Wienerschnitzel Chili Cheese Dog All Meat Hot Dog with Chili & Cheese on a Whole Grain Hot Dog Code #C96100/960000
Cafe Favorites Oven Roasted Turkey Breast & Cheese Deli Flatz-IW Code #C22348/22348
Integrated Food Service Italian Submarine Sandwich Code #C140004/C14004
Cafe Favorites Turkey Ham, Egg & Cheese Sunrise Twist Code #C51140/51140
Integrated Food Service Turkey Breast & Cheese Sandwich on a Whole Grain French Roll Code #C16001/160001
Integrated Food Service Chicken Little Sliders-Wrapped Code #809050
Integrated Food Service Turkey Ham & Cheese Sandwich Code #C13001/130001
Integrated Food Service BBQ Rib Sandwich BBQ Rib Beef Patty on a Whole Grain Roll Code #460007
Cafe Favorites Turkey Sausage & Cheese Sunrise Twist Code #C52140/52140
Integrated Food Service Submarine Sandwich on a Whole Grain Ciabatta Roll Code #C14006/140006
Cafe Favorites Cold Cut Combo on a Whole Grain Knot Roll Code #C02372/02372
Integrated Food Service Beef Sausage & Cheese on a Mini Bagel Code #809016/C80916-CH Code #C80916
Integrated Food Service Turkey Breast & Cheese Sandwich on a Whole Grain Ciabatta Roll Code #C16006/160006
Cafe Favorites Turkey Ham & Cheese Deli Flatz Code #C22148/22148
Cafe Favorites Turkey Ham & Cheese Melt on a Knot Roll Code #C02172/02172
Integrated Food Service Cheeseburger Sliders Mini Slider Beef Patty and Cheese on a Whole Grain Bun Code #470220/C47220-CH
Cafe Favorites Turkey Ham & Cheese Submarine Code #C02184/02184
Integrated Food Service Low Sodium, Reduced Fat Chili Cheese Dog Chicken Hot Dog with Chili & Cheese on a Whole Grain Hot Dog Bun Code #C95200/952000
Cafe Favorites Oven Roasted Turkey Breast & Cheese Melt on Knot Roll Code #C02272/02272
Integrated Food Service Turkey Ham & Cheese Sandwich on a Whole Grain Hawaiian Bun Code #130018/C13018
Super Sub on a Whole Grain Hoagie-IW Code #C02384/02384
Integrated Food Service All American Cheese Burger Beef Patty and Cheese on a Whole Grain Bun Code #471007/C47107-CH
Integrated Food Service Teriyaki Burger Beef Patty on a Whole Grain Hawaiian Bun Code #C48008
Williams Chipotle Chili Seasoning, Net Wt. 1 1/8 OZ. (32 g). Williams Foods, Inc. Lenexa, KS 66215. Packaged in paper pouches.
Williams Chipotle Taco Seasoning, Net Wt. 1 1/4 OZ. (35.4 g). Williams Foods, Inc. Lenexa, KS 66215. Packaged in paper pouches.
MX 16-slice SKD whole body computed tomography X-ray system. Imaging diagnostic tool.
MX 16-slice whole body computed tomography X-ray system. Imaging diagnostic tool.
Blood and Blood Products for Reprocessing
Albuterol Sulfate Syrup, 2 mg/ 5 mL, 473 mL bottle, Rx only, Manufactured in Canada by Contract Pharmaceuticals Limited, Canada, Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA --- NDC 0093-0661-16
Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a Radiofrequency Generator to create radiofrequency lesions in nervous tissue.
Richard Allan Scientific 10% Neutral Buffered Formalin, Part Number: 53901 and 561201 Item 53901 90ml bottle, 125 per case; Item 561201 120ml bottle, 75 per case.
Pediatric Flowmeter adapts to lnvacare Concentrators for low-flow usage.The gauge has a scale printed on the front side and the back side. The front scale is the primary source for monitoring oxygen flow. The rear scale is an aide for monitoring oxygen flow.
lnvacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16. Packed one per carton. The lnvacare Precise Rx Pediatric Flowmeter adapts to lnvacare Concentrators for low-flow usage.The gauge has a scale printed on the front side and the back side. The front scale is the primary source for monitoring oxygen flow. The rear scale is an aide for monitoring oxygen flow.
Raw Refrigerated Cucumbers, 11/9 bushel, 6 count, 12 count, 24 count, in corrugated cardboard cases, Southern Valley Produce Lot 16300705. (The product was either distributed in original container or were repackaged).
cones, 32 oz. box, Manufactured by Mister Cookie Face LLC, Lakeland, NJ and Distributed by Aldi, Batavia, IL 60510, UPC 041498191962
Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for patients.
Volker 2080, 2082, S 280 and S 282 series beds with lateral release button. A/C Powered Adjustable Hospital Bed Product Usage: Volker model 2080/3010/3080 nursing beds are intended for the care of residents in rooms in nursing homes, in residential homes for the elderly and in suitable rooms in private residences. They may not, however, be used for transportation purposes. Any deviation from this use is expressly excluded from possible liability claims.
Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile, Used to complement or replace the standard instruments used during the implantation of hip, knee, trauma and upper extremities implants
OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 634459, OptraPol Refill Small Flame/10: REF/Product ID 634458, OptraPol Assortment: REF/Product ID 634464 --Device Listing # B106952. One step polishing system for all common dental composites and amalgam.
Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6541-4-808, Lot 123, NDC M546654148080S Product Usage: Is a reusable instrument that is part of the Triathlon Primary total knee arthroplasty (TKA) system as well as the Triathlon Partial Knee Replacement (PKR) system. The use of the handles in Primary TKA is optional and may be used to: (1) Assist in stabilizing the Triathlon Femoral Sizer, (2) Aid in stabilization during use and removal of the Triathlon 4:1 Cutting Block and (3) Aid in assembly of the Anterior MIS Distal Resection Guide to the Anterior Skim Cut Guide. Per the Triathlon PKR surgical protocol, the handle is required for a PKR surgery and is used to: (1) Assemble and disassemble the Femoral Trial Drill Guide into the Femoral Trial and (2) Remove the Peg Trial from the Femoral Trial.
Artis zee/ zeego, Artis Q/ Q.zen, stand alone system, software controlled Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959, 10848281, 10848282, 10848283, 10848353, 10848255 Artis zee / zeego and Q/ Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee / zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee / zeego and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.
Medicine Cup, 1 OZ. Liquid medication dispenser to issue a measured amount of liquid medication.
Servo Humidifier 163, Model 01-06-8125-8, REF 6419365 Product Usage: A heat and moisture condenser (artifical nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidity gases breathed in by the patient.
Snack Factory Original Pretzel Crisps, Thin, Crunchy Pretzel Crackers. Made in a facility that processes Milk and Soy. Distributed by: Snack Factory, PO Box 6917, Hanover, PA 17331 Sold in the following sizes and UPC codes: 12 ct / 116 oz. Net Wt 26 oz (l lb 10 oz.) 737g, UPC 49508-00692, Net. Wt. 30 oz. (1 lb. 14 oz.) 850 g, UPC 49508-25040
STAPLER 30, IS4000, model number 470430; Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediatric use. The device can be used with staple line or tissue buttressing material.
CURVED-TIP STAPLER 30,IS4000, model number 470530; Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediatric use. The device can be used with staple line or tissue buttressing material.
Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087
AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM, system, x-ray, angiographic AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen systems can also support the acquisition of position triggered imaging for spatial data synthesis.
ARTIS ZEE AND ZEEGO, system, x-ray, angiographic AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen systems can also support the acquisition of position triggered imaging for spatial data synthesis.
ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM, interventional fluoroscopic x-ray system22 AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen systems can also support the acquisition of position triggered imaging for spatial data synthesis.
Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Plate, Fixation, Bone, Orthopedic Devices The 2.4mm Titanium Locking Screw Self-Tapping with Stardrive Recess 12mm is a part of the following systems: - 2.4. mm Titanium LCP Distal Radius Plate System - Titanium LCP Compact Distal Radius System - 2.4 mm Titanium LCP Radial Head Plate Set - Titanium Modular Mini Fragment LCP System - 2.4 mm Titanium Variable Angle LCP Distal Radius System - 2.7 mm/3.5 mm Titanium Distal Fibula Plate System
Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system. The system can perform single shot photocoagulation as is performed conventionally.
Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusable instrument which is part of the Exeter femoral hip system. Exeter femoral rasps are assembled with the rasp handle and locked in place by closing down the lever on the rasp handle. The rasp handle is then used to guide the rasp into the patients femur and is impacted using a mallet in order to remove bone and further prepare the femur.
Integra External Fixation System Slotted Post - Small Catalogue #12224228; Integra External Fixation System Slotted Post Large Catalogue #12224229
Integra External Fixation System Universal Wire Fixation Bolt - 17.5 mm Catalogue #12224218 ; Integra External Fixation System Universal Wire Fixation Bolt - 23 mm Catalogue #12224219
NucliSENS easyMAG Magnetic Silica The NucliSENS easyMAG accessory products are reagents and disposable to be used with the bioMerieux extraction systems which mention these products in their User Manuals. They enable the automated extraction (purification and concentration) of total nucleic acids (RNA/DNA) from biological samples which are liquid and homogeneous. These products are intended for in vitro diagnostic use by healthcare professionals only.
VITROS Immunodiagnostic Products Estradiol Reagent Pack, Unique Device Identifier No. 10758750005017, REF/Catalog Number/Product Code 855 2630; IVD -- Ortho-Clinical Diagnostics, Pencoed, Bridgend CF35 5PZ, UK --- The VITROS Estradiol test is performed using the VITROS Estradiol Reagent Pack and Calibrators on VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic Systems and VITROS 5600 Integrated Systems.
Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.
Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
, id # 79423. Article # 38072, Nobel Parallel CC Guided Surgery Kit. The Guided Surgery Kit is used as part of the installation process of NobelParallel CC Implants. The purpose of the IFU is to instruct the user how to use the products safely. The purpose of the manual is to guide the user through the usage of NobelGuide for NobelParallel CC.
BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD); Catalog number 340383. Label states: Contains CD3 FITC/CD4 PE/CD45 per CP with Gelatin and 0.1% sodium azide. Hematology: BD Tritest CD3 fluorescein isothiocyanate (FITC)/CD4 phycoerythrin (PE)/CD45 peridinin chlorophyll protein (PerCP) is a three-color direct immunofluorescence reagent for use with a suitably equipped flow cytometer to identify and determine the percentages and absolute counts of mature human T lymphocytes (CD3+) and helper/inducer (CD3+CD4+) Tlymphocyte subsets in erythrocyte-lysed whole blood.
Zinc Acetate, Crystal, USP, packaged in 500 gram bottles, Spectrum Chemical MFG, CORP., New Brunswick, NJ 08901

Product Quantity
903 Cases and 4,090 Sleeves (8,605,000 Medicine Cups)
49 sites potentially have the affected versions

Reason for Recall
Foreign matter (plastic) was observed in the product.
CPU board failures cause fowler (backrest) electronic controls to stop working.
The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric Bed. They discovered that the Junction Box may omit sparks which could result in a fire in the presence of flammable materials.
Software defect causing intermittently slow response of Host.
Software issues found in v4.1 .3/4.1.5 in the Philips Brilliance iCT/ iCT SP products that could affect the performance of the equipment.
Software issues in v4.1.3/4.1.4/4.1.5 in the Philips Ingenuity CT products that could affect the performance of the equipment.
Software issues found in software versions v4.1.3/4.1.4/4.1.5 in the Philips Brilliance 64 products that could affect the performance of the equipment.
Software issues in software versions v4.1.3/4.1.4/4.1.5 in the Philips Brilliance 64 and Ingenuity CT products that could affect the performance of the equipment.
Software issues in versions v4.1 .3/4.1.5 in the Philips Brilliance iCT) iCT SP products that, could affect the performance of the equipment.
Chili and taco seasoning products contain an ingredient which was recalled for potentially containing undeclared wheat allergen. Testing revealed the presence of gluten. Wheat is not declared on the label.
The following issues have been found in MX 16-slice systems with software version 1.1.4.21426: 1. During the filming operation on MX16-slice console software, the clipboard used for copying and pasting images is not cleared between patients. If the operator fails to copy the current patients images before pasting, a previous patients images may be present in the clipboard and be copied onto the film of the current patient. 2. During the Bolus Tracking scan, if the Auto Voice in Tracker scan is enabled, the Tracker scan will be aborted unexpectedly and the diagnostic scan after the tracker scan needs to be manually started. 3. If the scan protocol with SAS (Spiral Auto Start) function is selected to plan the scan, the SAS option may not be displayed on the Contrast tab of the scan protocol parameter area or the SAS option is displayed but not enabled as pre-configured in the protocol. This issue only occurs on the first helical scan after system startup that applies SAS function
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Blood product, manufactured without additive solution, was distributed.
Presence of Foreign Substance; presence of black particles describes generically as cellulose-based bundles of brown fibrous material.
Software defect, where either an Above Assay Range or an inaccurate value could potentially be reported, in the Stratus CS Acute Care Diagnostics System regarding TestPak calibration and quality control (QC) status when a TestPak is due to expire within 48 hours.
Mismatch between the length of the RF electrode (probe) and the cannula (introducer),
potential contamination with potassium hydroxide may have an impact when performing immunohistochemistry testing. It is unknown whether the contamination will affect tissue antigenicity. If it were to affect tissue antigenicity, the outcome would be risk of false positive or false negative test results which may lead to serious injury. There is the possibility the patient may need to be re-biopsied.
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Blood products, collected from a donor for whom donor suitability was not adequately determined, was distributed.
The rear gradation scale was screen printed upside down on the flowmeter gauge.
A sample of raw cucumbers tested positive for Salmonella spp.
Ice Cream Cones are being recalled because they may contain peanuts which are not declared on the allergen statement.
An internal review of an available product found that the Information For Use only contained English and Japanese languages when a CE-marked 23 language version was expected.
The current construction of the side rail latch may not be able to support the full patient weight and may give way allowing the side rail to abruptly lower and the patient to fall, potentially resulting in harm. To date there has been one report of a related injury.
It was reported that the secondary locking mechanism, and its corresponding components, disassociated from the Specialty Triathlon Tibial Alignment Handle with Secondary Lock Assembly during surgery. Upon further investigation, it was discovered that the weld, which was intended to hold the secondary locking mechanism together, did not meet the weld size specified on the engineering drawing.
After a few seconds of polishing with moderate force, parts of the OptraPol cup are breaking away. OptraPol Small Flame is also affected. Two complaints were filed referring to OptraPol, claiming that the abrasive polishers wear faster than expected.
Stryker Orthopaedic is voluntarily recalling the Triathlon Modular Handle because analysis revealed that the press fit specifications between the dowel pin and the mating hole in the shaft were not being achieved potentially resulting in disassociation from the instrument.
Blood product, in which donor screening/donor record incomplete or incorrect, was distributed.
Blood product, in which quality control and distribution of product did not meet specifications, was distributed.
Due to an error in the 19 Live Display, image reproduction may fail in the examination room and the potential exists for the loss of images immediately after system startup.
There is 5 mL printed next to the increment on the medicine cups instead of 10 mL. The cup has the correct mL markings for the other gradations, but sequentially, the markings are listed as 2.5 mL, 5 mL, 7.5 mL, and 5 mL.
Cracks may occur at the 15mm and 22mm ISO female connector.
Baptista's Bakery is recalling The Snack Factory 30 oz. Original Pretzel Crisps due to undeclared milk, because it may contain seasoned pretzel crisps which utilize dairy in their topical seasoning application.
Apheresis product, collected from a donor with a HTLV repeatedly reactive donation was distributed.
An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced a Stapler Firing Failed message as well as review of da Vinci Xi Surgical System logs found an increased trend
The firm discovered that the centrifugal force applied to the power supply may cause it to fail over time. The exam performed at the time of the failure will likely be lost, resulting in the need to rescan the patient.
The possibility exists for contaminants, in the form of biomass, to develop in the cooling system of Artis systems resulting in damage to the pump system.
It was reported that the specified lots of the 2.4mm Titanium Locking Screw Self-Tapping with Stardrive Recess 12mm can break between the head and the shaft. This resulted from the neck feature being too close to the StarDrive feature leaving a thin wall between neck and drive.
Topcon discovered an anomaly with titration, only when EpM is turned on during the titration process. This event may occur if the user turns on EpM, turns off the Landmark (LM) function (with any EpM supported pattern) and then enters titration mode.
Malfunctioning of the Exeter Rasp/trial introducer/extractor Handle.
Through the investigation of reported complaints Integra verified that there have been instances where the Universal Wire Fixation Bolts the Slotted Post broke during use at the surgical site.
Several customer complaints about amplification performance issues when using different batches of MagSil with the NucliSENS easyMAG extraction platform.
Ortho Clinical Diagnostics has issued a recall of their VITROS immunodiagnostics Estradiol Reagent assay. The firm was made aware of a potential cross-reactivity between the drug Fulvestrant and theVITROS Immunodiagnostic Estradiol Reagent assay. The firm conducted an internal investigation and was able to confirm biased positive (ranging from 1303-4046%) on Estradiol results, obtained from postmenopausal females taking Fulvestrant.
Apheresis product, collected from a donor who had not had an annual physical exam performed, was distributed.
Blood product mislabeled with incorrect Rh antigen type was distributed.
The patient name in the Halo title bar and the thumbnails do not match the name on displayed images.
When measuring a lesion on an unmagnified mammography image then performing the same measurement on an image magnified by the Hologic imager (different image), the measurements are not the same.
Incorrect drill protocol in the Instructions for Use (IFU)
Internal review found that some vials of CD3/CD4/CD45 state that the product contains gelatin. The product does not contain gelatin and should state in buffer.
Blood product, collected from a donor who was allowed to donate without a current physical, was distributed.
Blood product, for which Chagas Disease testing was not performed, was distributed.
Does not meet monograph: product exhibits lead levels in excess of the USP monograph limits.

Code Info
UPC 03447 02385, Manufacture lot code: Oct 1316F (stamped on the rear of the bag).
All software versions and serial numbers
Lot Numbers NGAN1721, NGAN1765, NGAP1807, NGAP2009, NGZK5402, NGZKY606, NGZKY607, NGZL3822
All beds (serial numbers) in the 2080, 2082, S 280 and S 282 series are affected by this field action except for those without siderails. The models are as follows: 2080, 2082, 2080 C, 2080 E, 2080 FS, 2080 K, 2080 LP, 2080 MA, 2080 MB, 2080 S, 2080 SL, 2080 SONDER, 2082 SONDER, S280, S280 SONDER, S282, S282 SONDER.
REF/Product ID 634459: Lot UL0843; REF/Product ID 634458: Lot VL0704; REF/Product ID 634464: Lot VL0705.
16 oz.: Item Code 110608, Lot Code: BB070165A 03, Best By Date 07-01-17; 26 oz.: Item Code 110692, Lot Code: BB070162A 03, Best By Date 07-01-17; 30 oz.: Item Code 108105, Best By Date 07-01-17.
Lot Number: 9942217 Part Number: 412.812
Lots - Z017BB1MS, Z017BF1MS, Z017CA1MS, Z017BE1MS, Z017CC1MS, Z017CD1MS, Z017CH1MS, Z017BD1MS, Z017DB1MS, Z017BA1MS, Z017CF1MS, Z017CE1MS, Z017CG1MS, Z017DA1MS, Z017DC1MS, Z017DD1MS, Z017EA1MS, Z017EB1MS, Z017FB1MS, Z017KF1MS, Z017KG1MS, Z017KH1MS
Lot numbers: 1470 (expiry date 02-Aug-16); 1480 (expiry date 05-Aug-16), 1490 (expiry date 10-Oct-16), 1500 (expiry date 10-Oct-16), 1510 (expiry date 01-Nov-16), 1528 (expiry date 01-Nov-16) 1538 (expiry date 14-Mar-17), 1548 (expiry date 09-Mar-17), 1558 (expiry date 09-Mar-17) and 1568 (expiry date 29-Mar-17)