Atorvastatin Calcium 40mg Tablet, 30-count bottles, Rx only, Pk By Safecor Health Woburn, MA 01801, NDC 60505258009
Acyclovir 400mg Tablet, 15-count bottles, Rx only, Packaged by Safecor Health, LLC. Woburn, MA 01801, NDC 0093894305
Acetaminophen 325mg tablets, 120-count bottles, Pk By Safecor Health Woburn, MA 01801, NDC 00904198280.
Doxycycline100mg Tablets, 14-count bottles, Rx only, Packaged By Safecor Health LLC Woburn, MA 01801, NDC 0143314205
Metronidazole 500mg Tablet, 50-count bottles, Rx only, Packaged By Safecor Health LLC  Woburn, MA 01801, NDC 5011133402
Calcium Carbonate 600mg/Vitamin D3 400 International Units tablets, 60-count bottles,  Pk By Safecor Health Woburn, MA 01801, NDC 00904323392.
Worldwide Distribution - US (nationwide)    Foreign: Argentina, Australia, Belgium, Brazil, Bridgend Wales, Canada, Chile, Colombia, Dominican Republic, England, Eschbach, France, India, Italy, Japan, Jordan, Korea, Malaysia, Mexico, Netherlands, Nicaragua, Panama, Peru, Russia, Saudi Arabia, Singapore, Spain, Switzerland, Taiwan, Thailand
Segmental fluted stem, 15x250mm bwd, Sterile,   Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants
Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
Item Number: 00585205415, Lot Number Expiry Date Before: March 2027
Fem IM Nail 14mmdx50cm left, Sterile,   Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Item Number:00225750004, Lot Number Expiry Date Before: March 2027
Fem IM Nail 14mmdx48cm left, Sterile,   Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Item Number:00225748004, Lot Number Expiry Date Before: March 2027
Por fullct fem st 15x200mm, Sterile,   prosthesis, hip, semi-constrained, metal/polymer, porous uncemented- Specific Knee, Hip and Nail Implants
Item Number: 00784301508, Lot Number Expiry Date Before: March 2027
Fem IM Nail 16mmdx42cm, Sterile,   Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Item Number: 00225242016, Lot Number Expiry Date Before: March 2027
Item Number: 00784301608, Lot Number Expiry Date Before: July 2026
Por fullct fem st 20x200mm, Sterile,   Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Item Number: 00784302008, Lot Number Expiry Date Before: July 2026
Fem IM Nail 16mmdx38cm, Sterile,   Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Item Number: 00225238016, Lot Number Expiry Date Before: March 2027
Segmental malefemale taper, 200mm, Sterile,   Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Item Number: 00585004620, Lot Number Expiry Date Before: March 2027
Fem IM Nail 16mmdx48cm, Sterile,   Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Item Number:00225248016, Lot Number Expiry Date Before: March 2027
Xl por st 25.5x220mm, bowed\, bowed, Sterile,   Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Item Number: 00992125533, Lot Number Expiry Date Before: March 2027
Segmental fluted stem, 19x250mm bwd, Sterile,   Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Item Number: 00585205419, Lot Number Expiry Date Before: July 2026
Item Number: 00784301708, Lot Number Expiry Date Before: July 2026
Fem IM Nail 15mmdx44cm, Sterile,   Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Item Number: 00225244015, Lot Number Expiry Date Before: March 2027
Segmental fluted stem, 16x250mm bwd, Sterile,   Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants
Item Number: 00585205416, Lot Number Expiry Date Before: July 2026
Fem IM Nail 15mmdx48cm, Sterile,   Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Item Number:00225248015, Lot Number Expiry Date Before: March 2027
Segmental fluted stem, 19x190mm str, Sterile,   Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants
Item Number: 00585205219, Lot Number Expiry Date Before: March 2027
Fem IM Nail 15mmdx50cm, Sterile,   Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Item Number:00225250015, Lot Number Expiry Date Before: March 2027
Fem IM Nail 14mmdx50cm right, Sterile,   Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Item Number:00225750014, Lot Number Expiry Date Before: March 2027
Fem IM Nail 16mmdx40cm, Sterile,   Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Item Number: 00225240016  , Lot Number Expiry Date Before: March 2027
Item Number: 00784301808, Lot Number Expiry Date Before: July 2026
Fem IM Nail 16mmdx50cm, Sterile,   Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Item Number:00225250016, Lot Number Expiry Date Before: March 2027
Xl por st 24.0x220mm, bowed, Sterile,   Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Item Number: 00992124033, Lot Number Expiry Date Before: March 2027
Fem IM Nail 15mmdx46cm, Sterile,   Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Item Number:00225246015, Lot Number Expiry Date Before: March 2027
Segmental malefemale taper, 220mm, Sterile,   Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants
Item Number: 00585004622, Lot Number Expiry Date Before: March 2027
Fem IM Nail 14mmdx48cm right, Sterile,   Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Item Number:00225748014, Lot Number Expiry Date Before: March 2027
Segmental fluted stem, 18x250mm bwd, Sterile,
Item Number: 00585205418, Lot Number Expiry Date Before: July 2026
Segmental fluted stem, 18x190mm str, Sterile,   Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants
Item Number: 00585205218, Lot Number Expiry Date Before: March 2027
Segmental fluted stem, 17x250mm bwd, Sterile,   Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants
Item Number: 00585205417, Lot Number Expiry Date Before: September 2026
Fem IM Nail 16mmdx44cm, Sterile,   Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Item Number: 00225244016, Lot Number Expiry Date Before: March 2027
Segmental fluted stem, 17x190mm str, Sterile,   Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants
Item Number: 00585205217, Lot Number Expiry Date Before: March 2027
Segmental vss bowed 19x190mm, Sterile,   Hip joint, metal/ceramic/polymer, semi-constrained, cemented or nonporous uncemented prosthesis- Specific Knee, Hip and Nail Implants
Item Number: 00585207419, Lot Number Expiry Date Before: March 2027
Fem IM Nail 16mmdx46cm, Sterile,   Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Item Number:00225246016, Lot Number Expiry Date Before: March 2027
Tibial IM Nail 15mmdx44cm, Sterile,   Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Item Number:00225344015, Lot Number Expiry Date Before: March 2027
Complete Pharmacy and Medical Solutions LLC
Human Chorionic Gonadotropin, 125 IU HCG, in 0.5 ml syringe, subcutaneous administration, Rx only,  Complete Pharmacy & Medical Solutions, Miami Lakes, FL 33014
Non-sterility: presence of mold confirmed by outside laboratory at the 14 day culture.
Human Chorionic Gonadotropin, 15,000 IU per vial, lyophilized for injection, Rx only,  Complete Pharmacy & Medical Solutions, Miami Lakes, FL 33014
Non-sterility - presence of bacteria confirmed by outside laboratory after day 14.
AAHU BARAH, DRY FIG, NET WT. 1 LB, PRODUCT OF PAKISTAN
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Worldwide Distribution in the states of IL, PR, CA, OR, MI, FL, NY, TX, OK, GA, VA and country of CHILE
Pointe Scientific Hitachi Total Bilirubin Rl Reagent    Product Usage:  Two part Chemistry Reagent Hitachi Total Bilirubin Rl Reagent is used with Hitachi Total Bilirubin R2 Reagent for the quantitative determination of total bilirubin in serum on Hitachi analyzers. For in vitro diagnostic use only.
MN, WI    AL, AZ, CA, CO, GA, IA,IN, KS,MI, NC, NY, OH,OR,  PA, SC, TX.
Chocolate chip cookie dough larabars, 10 count , UPC 100-21908-49031 incorrectly packaged in peanut butter cookie larabars boxes, 10 count, UPC000-21908-49154.
Chocolate chip cookie dough larabars which contain cashews were incorrectly packaged in peanut butter cookie larabars boxes. The individual labeling on the chocolate chip cookie dough larabars is correct despite being in the wrong boxes.
Nationwide distribution in the U.S, including military and government sites.   The product was also distributed to Algeria, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia - Herzegovina, Brazil, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroun, Canada, Chad, Chile, China, Colombia, Congo, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Gabon, Gambia, Georgia, Germany, Greece, Grenada, Guatemala, Guinea, Haiti, Honduras, Hungary, India, Indonesia, Iraq, Israel, Italy, Ivory Coast, Japan, Jordan, Kazakhstan, Kenya,  Uganda, Kuwait, Laos, Latvia, Lebanon, Lithuania, Malaysia, Mali, Malta, Mexico, Mongolia, Morocco, Mozambique, Myanmar, Netherlands, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam,  and Zimbabwe.
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
VITEK 2 Gram Negative Susceptibility card (AST-GN13), REF 22095, 20 cards per carton.
VITEK 2 Gram Negative Susceptibility card (AST-GN16), REF 22139, 20 cards per carton.
VITEK 2 Gram Positive Susceptibility card (AST-P577), REF 22218, 20 cards per carton.
VITEK 2 Bacillus identification card (BCL),  IVD, REF 21345, 20 cards per carton.
VITEK 2 Gram Negative Susceptibility card (AST-GN09), REF 22008, 20 cards per carton.
VITEK 2 Yeast identification card (YST),  IVD, REF 21343, 20 cards per carton.  .
VITEK 2 Gram Negative Susceptibility card (AST-N102), REF 22258, 20 cards per carton.
VITEK 2 Gram-Positive identification card (GP),  IVD, REF 21342, 20 cards per carton.
VITEK 2 Gram Negative Susceptibility card (AST-GN38), REF 22331, 20 cards per carton.
VITEK 2 Anaerobic and Corynebacteria identification card (ANC), REF 21347, 20 cards per carton.
VITEK 2 Neisseria-Haemophilus identification card (NH),  IVD, REF 21346, 20 cards per carton.
VITEK 2 Gram Negative Susceptibility card (AST-GN14), REF 22096, 20 cards per carton.
Domestic: Puerto Rico, AK  AL  AR  AZ  CA  CO  CT  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    Foreign: CANADA, ALGERIA                    ARGENTINA  AUSTRALIA                  BELGIUM  BRAZIL  BRIDGEND WALES  CHINA  DUBAI UAE                  EGYPT                      EL SALVADOR                ENGLAND  ESCHBACH GERMANY  EXPORT DORAL FL  FRANCE                     GERMANY  GUATEMALA                  HONDURAS  INDIA  ITALY  JAMAICA  JAPAN  JORDAN  KOREA  LEBANON                    DELIVERY SERVICE (LYNBROOK  NY)  MALAYSIA  MEXICO  MIAMI FL  MOROCCO  NETHERLANDS                NEW ZEALAND  NICARAGUA                  PANAMA  PERU  PHARR TEXAS  POLAND  PUERTO RICO  RIO DE JANEIRO  SAUDI ARABIA               SINGAPORE  SPAIN  SWITZERLAND  TAIWAN  THAILAND  THE NETHERLANDS            TRIPOLI  UK  VIRGIN ISLANDS  VA/DOD: Both see addresses below
FEM IM NAIL 14MMDX30CM LEFT, FEM IM NAIL 14MMDX30CM RIGHT  FEM IM NAIL 13MMDX32CM LEFT  FEM IM NAIL 14MMDX32CM LEFT  FEM IM NAIL 13MMDX32CM RIGHT  FEM IM NAIL 14MMDX32CM RIGHT  FEM IM NAIL 11MMDX34CM LEFT  FEM IM NAIL 13MMDX34CM LEFT  FEM IM NAIL 14MMDX34CM LEFT  FEM IM NAIL 11MMDX34CM RIGHT  FEM IM NAIL 13MMDX34CM RIGHT  FEM IM NAIL 14MMDX34CM RIGHT  FEM IM NAIL 11MMDX36CM LEFT  FEM IM NAIL 12MMDX36CM LEFT  FEM IM NAIL 13MMDX36CM LEFT  FEM IM NAIL 14MMDX36CM LEFT  FEM IM NAIL 11MMDX36CM RIGHT  FEM IM NAIL 12MMDX36CM RIGHT  FEM IM NAIL 13MMDX36CM RIGHT  FEM IM NAIL 14MMDX36CM RIGHT  FEM IM NAIL 10MMDX38CM LEFT  FEM IM NAIL 11MMDX38CM LEFT  FEM IM NAIL 12MMDX38CM LEFT  FEM IM NAIL 13MMDX38CM LEFT  FEM IM NAIL 14MMDX38CM LEFT  FEM IM NAIL 10MMDX38CM RIGHT  FEM IM NAIL 11MMDX38CM RIGHT  FEM IM NAIL 12MMDX38CM RIGHT  FEM IM NAIL 13MMDX38CM RIGHT  FEM IM NAIL 14MMDX38CM RIGHT  FEM IM NAIL 10MMDX40CM LEFT  FEM IM NAIL 11MMDX40CM LEFT  FEM IM NAIL 12MMDX40CM LEFT  FEM IM NAIL 13MMDX40CM LEFT  FEM IM NAIL 14MMDX40CM LEFT  FEM IM NAIL 10MMDX40CM RIGHT  FEM IM NAIL 11MMDX40CM RIGHT  FEM IM NAIL 12MMDX40CM RIGHT  FEM IM NAIL 13MMDX40CM RIGHT  FEM IM NAIL 14MMDX40CM RIGHT  FEM IM NAIL 10MMDX42CM LEFT  FEM IM NAIL 11MMDX42CM LEFT  FEM IM NAIL 12MMDX42CM LEFT  FEM IM NAIL 13MMDX42CM LEFT  FEM IM NAIL 14MMDX42CM LEFT  FEM IM NAIL 10MMDX42CM RIGHT  FEM IM NAIL 11MMDX42CM RIGHT  FEM IM NAIL 12MMDX42CM RIGHT  FEM IM NAIL 13MMDX42CM RIGHT  FEM IM NAIL 14MMDX42CM RIGHT  FEM IM NAIL 10MMDX44CM LEFT  FEM IM NAIL 11MMDX44CM LEFT  FEM IM NAIL 12MMDX44CM LEFT  FEM IM NAIL 13MMDX44CM LEFT  FEM IM NAIL 14MMDX44CM LEFT  FEM IM NAIL 10MMDX44CM RIGHT  FEM IM NAIL 11MMDX44CM RIGHT  FEM IM NAIL 12MMDX44CM RIGHT  FEM IM NAIL 13MMDX44CM RIGHT  FEM IM NAIL 14MMDX44CM RIGHT  FEM IM NAIL 10MMDX46CM LEFT  FEM IM NAIL 11MMDX46CM LEFT  FEM IM NAIL 12MMDX46CM LEFT  FEM IM NAIL 13MMDX46CM LEFT  FEM IM NAIL 14MMDX46CM LEFT  FEM IM NAIL 10MMDX46CM RIGHT  FEM IM NAIL 11MMDX46CM RIGHT  FEM IM NAIL 12MMDX46CM RIGHT  FEM IM NAIL 13MMDX46CM RIGHT  FEM IM NAI
Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures.
TIBIAL I/M NAIL 15MMDX26CM, TIBIAL I/M NAIL 15MMDX28CM  TIBIAL I/M NAIL 15MMDX30CM  TIBIAL I/M NAIL 14MMDX32CM  TIBIAL I/M NAIL 15MMDX32CM  TIBIAL I/M NAIL 14MMDX34CM  TIBIAL I/M NAIL 15MMDX34CM  TIBIAL I/M NAIL 14MMDX36CM  TIBIAL I/M NAIL 15MMDX36CM  TIBIAL I/M NAIL 14MMDX38CM  TIBIAL I/M NAIL 15MMDX38CM  TIBIAL I/M NAIL 13MMDX40CM  TIBIAL I/M NAIL 14MMDX40CM  TIBIAL I/M NAIL 15MMDX40CM  TIBIAL I/M NAIL 13MMDX42CM  TIBIAL I/M NAIL 14MMDX42CM  TIBIAL I/M NAIL 15MMDX42CM  TIBIAL I/M NAIL 11MMDX44CM  TIBIAL I/M NAIL 13MMDX44CM  TIBIAL I/M NAIL 14MMDX44CM  TIBIAL I/M NAIL 11MMDX46CM  TIBIAL I/M NAIL 12MMDX46CM  TIBIAL I/M NAIL 13MMDX46CM
R-F IM NAIL 10MMDX48CM LG, 11MMDX42CM,   11MMDX44CM, 11MMDX46CM LG, 11MMDX48CM LG, 12MMDX46CM LG, 12MMDX48CM LG, 13MMDX40CM, 13MMDX42CM, 13MMDX44CM, 13MMDX46CM LG, 13MMDX48CM LG, 14MMDX34CM, 14MMDX36CM, 14MMDX38CM, 14MMDX40CM, 14MMDX42CM, 14MMDX44CM, 14MMDX46CM LG, 14MMDX48CM LG
Z NAIL PF 14MM X 46CM UNIV  Z NAIL GT 14MM X 46CM R  Z NAIL GT 14MM X 46CM L  Z NAIL TIBIA 14MM X 38CM UNIV  Z NAIL TIBIA 14MM X 40CM UNIV  Z NAIL TIBIA 14MM X 42CM UNIV  Z NAIL TIBIA 14MM X 44CM UNIV
FEM IM NAIL 15MMDX30CM,  FEM IM NAIL 16MMDX30CM  FEM IM NAIL 14MMDX32CM  FEM IM NAIL 15MMDX32CM  FEM IM NAIL 16MMDX32CM  FEM IM NAIL 14MMDX34CM  FEM IM NAIL 15MMDX34CM  FEM IM NAIL 16MMDX34CM  FEM IM NAIL 14MMDX36CM  FEM IM NAIL 15MMDX36CM  FEM IM NAIL 14MMDX38CM  FEM IM NAIL 15MMDX38CM  FEM IM NAIL 11MMDX40CM  FEM IM NAIL 13MMDX40CM  FEM IM NAIL 14MMDX40CM  FEM IM NAIL 15MMDX40CM  FEM IM NAIL 11MMDX42CM  FEM IM NAIL 12MMDX42CM  FEM IM NAIL 13MMDX42CM  FEM IM NAIL 14MMDX42CM  FEM IM NAIL 15MMDX42CM  FEM IM NAIL 11MMDX44CM  FEM IM NAIL 12MMDX44CM  FEM IM NAIL 13MMDX44CM  FEM IM NAIL 14MMDX44CM  FEM IM NAIL 10MMDX46CM  FEM IM NAIL 11MMDX46CM  FEM IM NAIL 12MMDX46CM  FEM IM NAIL 13MMDX46CM  FEM IM NAIL 14MMDX46CM  FEM IM NAIL 10MMDX48CM  FEM IM NAIL 11MMDX48CM  FEM IM NAIL 12MMDX48CM  FEM IM NAIL 13MMDX48CM  FEM IM NAIL 14MMDX48CM  FEM IM NAIL 13MMDX50CM  FEM IM NAIL 14MMDX50CM
VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H,    95DX20H, 95DX22H
Worldwide distribution.  US Nationwide including PR, and countries of AU, BE, CA, CL, CN, IL, IT, JP, KR, MX, PA, SA, SG, and TR.
CUSTOM SUTURE PACK; Item Number: US1540 and US1614
Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
VIOLET REEL   110T   D4L1169X  D4M0237X  D5A1288X  D5A1297X
GREEN CV-24 D-TACH; Item Number: 8886621933; MAXON 5/0 5X18 GR CV-23 D-TACH; Item Number: XX2109; MAXON* 4/0 5X30 GREEN V-20  D*TACH; Item Number: 8886603433
GREEN CV-24 D-TACH  D4K0396X  D4K2053X  D4L0541X  D4L1084X  D4L1272X  D4M0394X  MAXON 5/0 5X18 GR CV-23 D-TACH  D4K1485X  MAXON* 4/0 5X30 GREEN V-20  D*TACH  D4L1156GX
SCHRITTMACHER ANGIO X3; Item Number: 4045255423347
Potassium PHOSphate added to 0.9% Sodium Chloride, 7 mMol 100 mL Bag, Service Code 2K5284, NDC# 61553-0284-48, Total Volume 100.00 mL incorrectly labeled as 102.33 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
VANCOMYCIN HCl 1.5g in 300 mL 0.9% Sodium Chloride Injection USP, Service Code 2K2243, NDC# 61553-043-34, Total Volume 300.00 mL incorrectly labeled as 500.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
VANCOMYCIN HCl 1.5g in 300 mL 5% Dextrose Injection USP, Service Code 2K2227, NDC# 61553-027-34, Total Volume 300.00 mL incorrectly labeled as 500.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Potassium PHOSphate added to 0.9% Sodium Chloride, 20 mMol 100 mL Bag, Service Code 2K5287, NDC# 61553-0287-48, Total Volume 100.00 mL  incorrectly labeled as106.67 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Potassium PHOSphate added to 0.9% Sodium Chloride, 7.5 mMol 100 mL Bag, Service Code 2K5298, NDC# 61553-0298-48, Total Volume 100.00 mL incorrectly labeled as 102.50 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
VANCOMYCIN HCl 1.75g in 300 mL 0.9% Sodium Chloride Injection USP, Service Code 2K2237, NDC# 61553-037-34, Total Volume 300.00 mL incorrectly labeled as 500.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Potassium PHOSphate in 0.5% Dextrose, 7.5 mMol in 100 mL, Service Code 2K5299, NDC# 61553-0299-48, Total Volume 100.00 mL incorrectly labeled as 150.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Potassium CHLORide added to 0.9% Sodium Chloride, 30mEq 100 mL Bag, Service Code 2K5824, NDC# 61553-0824-48, Total Volume 100.00 mL  incorrectly labeled as 115.00 mL, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141
Potassium PHOSphate added to 0.9% Sodium Chloride, 15 mMol 100 mL Bag, Service Code 2K5295, NDC# 61553-0295-48, Total Volume 100.00 mL incorrectly labeled as105.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Potassium CHLORide added to 0.9% Sodium Chloride, 10mEq 100 mL Bag, Service Code 2K5856, NDC# 61553-0856-48, Total Volume 100.00 mL  incorrectly labeled as 105.00 mL, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141
Potassium PHOSphate added to 0.9% Sodium Chloride, 10 mMol 100 mL Bag, Service Code 2K5288, NDC# 61553-0288-48, Total Volume 100.00 mL  incorrectly labeled as 103.33 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
Product was shipped to the following states: IL, KY, NC & WV.
Spinach Sold under the brand names of Harris Teeter Farmers Market, 10 oz bag, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC MATTHEWS, NC 28105 UPC 0 72036 88023 9 & Peak 10 OZ & 40 oz bags, PACKED BY THE HORTON FRUIT CO., INC. LOUISVILLE, KY 40218 UPC 0 78951 50002 3 & 30 lb totes
455cs/8/10 oz bags + 7cs/4/40 oz bags + 3/30 lb totes
The firm received notification from their supplier of possible listeria contamination.
Lot #820062; Hariss Teeter Best IF Used By: 05/11/17; Peak 10 oz Best If Used By: 05/11/17 40 oz bag 05/13/17; 30 lb totes F1ELD 1S3 4 28 17 G1ELD 1S3 4 27 17.
The devices have been distributed nationwide within the United States and the following countries: Australia, Belgium, Canada, Finland, Germany, Guatemala, Hong Kong, India, Ireland, Japan, South Korea, Kuwait, Malaysia, Netherlands, New Zealand, Puerto Rico, Saudi Arabia, Taiwan, and the United Kingdom.
reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and  sterilization of these products
All lots  Catalog numbers:  J-CRKP-042900
All lots  Catalog numbers:  J-EIE-051500
All lots  Catalog numbers J-PLC-751810 and  090100
All lots  Catalog numbers J-RSN-901600 and  090002
Worldwide Distribution - US (nationwide) and Canada
1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr., Introducer Catheter    2) Arrow PSI Kit
27,485 units distributed in U.S, 4,371 units distributed internationally
Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
Material number: ASK-09803-WBH1, ASK-09903-KH, CDC-09803-1A  Device Listing E433883
Arterial Catheterization Kit,   Arterial Line Kit with Sharps Safety Features  wire, guide, catheter  The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
27, 485 distributed in the U.S, 4,371 distributed Internationally
Material number: ASK-04018-CC, ASK-04510-HUM, ASK-04550-UHC,     Device Listing D025180
ARROWg+ard Blue CVC Kit  The ARROWg+ard Blue CVCs are intended to permit venous access to the central circulation
27,485 units distributed in U.S., 4,371 units distributed internationally
The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to:  -multiple infusions of fluids, medications, or chemotherapy  -infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values  -frequent blood sampling or blood/blood components infusions  -infusion of incompatible medications  -central venous pressure monitoring  lack of usable peripheral IV sites  -replacement of multiple peripheral sites for IV access
Material number: CDC-24301-1A, CDC-24306-1A    Device Listing D025398
Arrow Pressure Injectable PICC Kit  Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days  The Arrow Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.
The Arrow Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.
Material number: EU-04041-HPMSB, EU-05052-HPMSB, EU-05041-HPMSB  Device Listing D000801
Arrow MAC Two-Lumen Central Venous Access Kit  Introducer Catheter  The Arrow Two-Lumen Central Venous Access device permits venous access and catheter introduction to the central circulation
Material number: CDC-11242-1A  Device Listing D025760
1) ARROWg+ard Blue You-Blend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions  The large-bore two-lumen catheter permits venous access to the central circulation for rapid fluid administration, temporary or acute hemodialysis, apheresis and hemofiltration. It may be inserted into the jugular, subclavia, or femoral veins    Catheter, hemodialysis non-implanted
27,485 units distributed in the U.S., 4,371 units distributed internationally
Material number: CDA-22122-U1A, CDC-22141-1A CDC-26142-1A   Device Listing D025726
Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features.  The multiple-lumen catheter permits venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. The ARROWg+ard Blue Plus antimicrobial catheter is intended to help provide protection against catheter-related infections. It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use.    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
1) Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology  The Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring
Material number: ASK-45552-RWJ4    Device Listing D213817
1) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit  2) ARROWg+ard Blue PSI Kit  3) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit  4) ARROWg+ard Blue PSI Kit  The MACTM two-Lumen Central Venous Access Device with ARROWg+ard Blue permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins
27,485 untis distributed in U.S., 4,371 units distributed internationally
Arrow Multi-Lumen CVC Kit  The Arrow Two-Lumen Central Venous Access device permits venous access and catheter introduction to the central circulation.
1) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit  2) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features  3)Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue Plus (R) Catheter and Sharps Safety Features  4) Multi-Lumen Pressure Injectable Central Venous Catheterization Kit with Blue Flex Tip(R)ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features  5)Pressure Injectable ARROWg+ard Blue Plus (R) Multi-Lumen Central Venous Catheterization Kit  6)AGB+Multi-Lumen Central Venous Catheterization Kit  7) AGB+Pressure Injectable Multi-Lumen CVC Kit  The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access.    Catheter, Intravascular, Therapeutic, Short Term Less Than 30 days
Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Catheter, Percutaneous  The Arrow Single-Lumen Catheter permits venous access to the central circulation
Material number: Ask-04301-WBH  Device Listing D040650
USA (nationwide) Distribution .There was no foreign/government/military distribution.
Merge PACS software.  The firm name on the label is Merge Healthcare, Hartland, WI.
47 sites potentially have the affected versions
Merge PACS did not show unviewed images when the last view was skipped. There is a potential risk to health of a physician misdiagnosis because not all images are available for viewing.
Merge PACS software.   Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication, and storage of studies produced by digital modalities, including digital mammography
47 sites have the potentially affected versions
When cut lines are shown on an image, the lines may go from being vertical and then shift to horizontal causing confusion to the physician.  This may cause a misdiagnosis.
US and worldwide: Australia, Finland, France, United Kingdom
Kii Shielded Bladed trocars (CTB14) and Kii Low profile trocars (CTB23).
Due to possibility of insufficient sterilization.
Worldwide Distribution - US Nationwide in the states of WI, NJ, NY and countries of BRAZIL, ECUADOR, SINGAPORE, CANADA,
Palcam Supplement Acumedia PN 7987    Product Usage:  PALCAM Supplement is used with PALCAM Agar or PALCAM Broth as a supplement for the selective and differential enrichment of Listeria spp. From foods, dairy and environmental samples.
Contamination of product with possible Bacillus spp
Worldwide Distribution - USA (nationwide)  Distribution.
Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx only,  Hospira, Inc. Lake Forest, IL --- NDC 0409-3375-04
GMP Deviation; A foreign stopper was observed during packaging of a lot of product.
Domestic: AL  AR  AZ  CA  CO  FL  GA  HI  ID  IL  IN  KY  LA  MD  MI  MO  MS  NC  NM  NY  OH  OK  OR  PA  SC  TN  TX  UT  VA  WA  WI    Foreign: Austria, Australia, Argentina, Azerbaijan, Belgium, Bulgaria, Bahrain, Canada, Chile, China, Cyprus, Czech Republic, Denmark, Djibouti, Egypt, France, Hong Kong, Honduras, Croatia, Greece, Germany, Hungary, India, Ireland, Italy, Latvia, Malaysia, Morocco, Netherlands, Poland, Portugal, Puerto Rico, Saudi Arabia, Serbia, Spain, Slovenia, South Africa, Sri Lanka, Sweden, Singapore, Taiwan, Thailand, Tunisia, United Kingdom, and Uruguay
Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages
Correction to the product Instructions for Use because the current reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.
HLF-M273-H30   HLF-M365-H30   HLF-M550-H30   HLF-M940-H30   HLF-M273-HSMA   HLF-M365-HSMA   HLF-M550-HSMA   HLF-M940-HSMA
Domestic: FL  IN  LA  MS  NC  TX    Foreign:Argentina, Australia, Brazil, Canada, Czech Republic, Egypt, Estonia, France, Germany, Israel, Italy, Netherlands, Norway, Paraguay, Poland, Portugal, Russian Federation, Spain, Switzerland, Tunisia, Turkey, United Kingdom,    VA/DOD:None
Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber Optic, Supplied sterilized by ethylene oxide gas in peel-open packages
Cook Inc. is initiating a voluntary recall of the Vue Optic Visualization Source and the Flexor Vue Deflecting Endoscopic System because it was determined that the current reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.
Vue Optic Visualization Source, Catalog Number: FVO-150, GPN: G25343  Flexor Vue Deflecting Endoscopic System  Catalog Number: FV-090075-150, GPN: G50972  Catalog Number: FV-090045-150, GPN: G34306
Worldwide Distribution - US Nationwide in the states of:  AK  AL  AZ  CA  CO  FL  GA  HI  IA  ID  IL  IN  KS  KY  LA  MA  MD  ME  MI  MN  MO  MS  MT  NC  NJ  NY  OH  OR  PA  SC  SD  TN  TX  WA  WI    Foreign: Australia, Bolivia, Brazil, Canada, Chile, Columbia, Cyprus, Czech Republic, Germany, Dominican Republic, Greece, Hong Kong, Ireland, Israel, India, Iran, Jordan, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Latvia, Libya, Mexico, Malaysia, New Zealand, Oman, Panama, Peru, Portugal, Serbia, Turkey, Trinidad and Tobago, Taiwan, and Venezuela.  VA/DOD: Yes- see below
Cook Inc. is initiating a voluntary recall of the OptiLite Multi-Use Holmium Laser Fibers because it has been identified that the reprocessing instructions do not provide sufficiently detailed information for the cleaning, disinfection, and sterilization of these products.
OptiLite Multi-Use Holmium Laser Fibers, Catalog Numbers followed by GPN:  HLF-M273-CNV, G48611  HLF-M273-SMA, G48522  HLF-M365-CNV, G48613  HLF-M365-SMA, G48618  HLF-M550-CNV, G48615  HLF-M550-SMA, G48619  HLF-M940-CNV, G48617  HLF-M940-SMA, G48621  HLF-M273-CNV-CAN, G51777  HLF-M273-SMA-CAN, G51785  HLF-M365-CNV-CAN, G51778  HLF-M365-SMA-CAN, G51786  HLF-M550-CNV-CAN, G51779  HLF-M550-SMA-CAN, G51787  HLF-M940-CNV-CAN, G51780  HLF-M940-SMA-CAN, G51788
1,349 - (Total - US) and 352 (Total - OUS)
This field action serves to retrospectively document the actions that were taken by Pentax  to correct the loose suction arms on eleven (11) models of endoscopes and to notify FDA of these actions taken in 2010-2011.
Philips Electronics North  America Corporation
USA(nationwide) Distribution to the states of : AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KY, LA, MA, ME, MI, MN, MO, NC, ND, NE, NH, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA and WI
Philips DigitalDiagnost 3.1.x X-Ray System
During recent evaluations of the Philips DigitalDiagnost 3.1.x, we have identified a potential issue that may affect the performance of the equipment under certain conditions.
DigitalDiagnost Upgrade Release 3.1.x to 3.1.3
The product was distributed thru the United States.   Please see attached excel sheet for detailed information about the consignees.
Monica Novii Wireless Patch System    product Usage:  Novii Interface - The Novii Interface is an accessory to the Novii Pod which provides a means of interfacing the wireless output of the Novii Pod to the transducer inputs of a CTG Fetal monitor. The Novii Interface enables signals collected by the Novii Pod to be printed and displayed on a CTG Fetal Monitor and sent on to a central network, if connected. Novii Pod - The Monica Novii Pod is an intrapartum maternal-fetal monitor that non-invasively measures and displays fetal heart rate (FHR), uterine activity (UA) and maternal heart rate (MHR). The Novii Pod acquires and displays the FHR tracing from abdominal surface electrodes that pick up the fetal ECG (fECG) signal. Using the same surface electrodes, the Novii Pod also acquires and displays the UA tracing from the uterine electromyography (EMG) signal and the MHR tracing from the maternal ECG signal (mECG). The Novii Pod is indicated for use on women who are at >36 completed weeks, in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen.
Monica Novii Wireless Patch System-Potential battery damage and excess heat through prolonged charging.
See attached consignee list for affected device serial numbers.
Product was delivered to two distribution centers in Landover,  Maryland and Carlisle, Pennsylvania, one food bank in Lorton, Virginia, and one facility in Laurel, Maryland.
Bright Farms LEMON BASIL 0.75oz  package , The salad products packaged in clear, plastic clamshells with best by dates on the package .
According to the firm, they have detected metal in their product.  The firm learned of the problem through an  internal verification techniques. The firm believes there is a risk of a health hazard. an is enacting this recall.
Bright Farms Baby Spinach (4 oz. package) The salad products packaged in clear, plastic clamshells with best by dates on the package .
Bright Farms Mixed Greens 4oz package , The salad products packaged in clear, plastic clamshells with best by dates on the package .
Bright Farms Baby Romaine -  4oz package  , The salad products packaged in clear, plastic clamshells with best by dates on the package .
Bright Farms Spinach Blend (4 oz. package) , The salad products packaged in clear, plastic clamshells with best by dates on the package .
Bright Farms Baby Kale 3 oz. package , The salad products packaged in clear, plastic clamshells with best by dates on the package .
Bright Farms Spring Mix (4 oz. and 8 oz. package) , The salad products packaged in clear, plastic clamshells with best by dates on the package .
Bright Farms Basil (.75 oz. package) The salad products packaged in clear, plastic clamshells with best by dates on the package .
Bright Farms Arugula (4 oz. and 8 oz. package) (4 oz. and 8 oz. package) , The salad products packaged in clear, plastic clamshells with best by dates on the package .
Bright Farms  Thai Basil 0.75oz  package , The salad products packaged in clear, plastic clamshells with best by dates on the package .
Worldwide Distribution - US Nationwide in the states of CT, FL, ID, IN, KY, MA, MI, MN, MO, NE, NJ, NY, NC, OH, PA, RI, SD, TX, UT, WA and countries of Canada, Czech Republic, Denmark, Germany, Israel, & Portugal
Sheridan SHER-I-SLIP and SOFT-TIP Intubating Stylets are intubating stylets manufactured from galvanized carbon steel and aluminum rods that are coated with a blue PVC or polypropylene outer covering and are designed to be placed inside an endotracheal tube to obtain a desired shape during intubation.
Product size listed on the labeling is incorrect.
CA, MI, NE, AZ, MO, UT, IA, FL, CO, WA, TX,, NE, KS, IL, FL,  AL, IA
L.A. LUCKY BRAND SWEET BASIL SEEDS: Hot E  2.1 OZ  (60 G) BAGS; 100 BAGS PER CASE;  Product of Vietnam.  Ingredients: Sweet Basil Seeds  Serving Size 1.05 oz. (2 servings per container)      Distributed by L.A. Lucky Import & Export, Inc., Bell, CA 90201
100 cartons (100 BAGS X 2.1 OZ (60 GRAM) = CASE )
During follow-up investigation of imported Basil Seeds that were refused for the presence of Salmonella, it was discovered that 100 out of 300 cartons had been distributed.
Product was distributed to the following states: IN, KS, KY, MO, NE & OH.
Simple truth Dry Roasted Macadamia Nuts SEA SALT 12 oz bag UPC 0 1111 00247 8 DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202
The firm was notified that the product may be potentially contaminated with Listeria  monocytogenes.
Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of :  Japan, Jordan, Kazakhstan, Korea ( Republic of) Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritania, Mexico, Moldova, Morocco, Nambia, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Serbia, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietam and Yemen.
GE Healthcare Revolution EVO X-ray system
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
GE Healthcare lnnova IGS 540 ACT X-ray system
GE Healthcare Discovery NM/CT 670 CZT  X-ray system
GE Healthcare Discovery NM/CT 670. 670 Pro, 670 ES  X-ray system
GE Healthcare Discovery IQ   X-ray system
GE Healthcare Optima CT580; Discovery RT, CT590 RT  X-ray system
GE Healthcare  Discovery Ml DR X-ray system
GE Healthcare LightSpeed VCT X-ray system
GE Healthcare Discovery NM/CT 570c   X-ray system
GE Healthcare Optima CT660, CT680  X-ray system
GE Healthcare Discovery  Ml  X-ray system
GE Healthcare  Lightspeed RT16 X-ray system
GE Healthcare Optima CT520  X-ray system
GE Healthcare Discovery PET/CT 600,610, 690, 710: Optima PET/CT 560. 560FX    X-ray system
F1015L JBS Swine G/F #5 Meal KLF W/Linco;   medicated swine meal 40 Tons bulk.  Custom Bulk swine Feed medicated with Lincomix
Illegal drug combination with one drug being toxic to swine.  56 lbs of Zoamix substituted for 56 lbs of Lincomix in 40 Ton batch
OK, TX, WI, NJ, FL, WA, NY, LA, SD, IL, OR.  CANADA.
D'Allesandro Woodland Foods  De-stemmed Birdseye Chiles   1, 5, and 35 lbs., food service,  bag in box container, singe unit per case.
Trace amounts of undeclared peanut found in product
NasalCrom (cromolyn sodium) Nasal Spray, USP, 5.2 mg per spray, 200 metered sprays, 0.88 FL OZ (26 mL) metered spray pump bottle, Distributed by: Medtech Products, Inc., Tarrytown, NY  10591, UPC 8 148332 01101 7.
CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product lot.
Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004USTMCA85200
Boston Scientific Zurpaz(TM) MEDIUM CURL, SYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004USMC85100
Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004EPTMCA85300
Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004EPTMCA85400
Worldwide Distribution - US Distribution to the states of : Ca and Oh., and to the countries of: Australia, Libya, China, Mayotte, Mexico, France, United Kingdom, Germany,  Ecuador, Australia, Spain, Switzerland, Macedonia, Uzbekistan, Kuwait, Malaysia, Netherlands, Argentina,  Chile, Colombia, Egypt, United Arab Emirates, Saudi Arabia, Hungary, Peru, Poland, Indonesia, Burkina Faso, Kazakhstan, Turkey and Slovenia.
Philips DuraDiagnost X-ray systems:   DuraDiagnost (R1.0, Product Number 712210)  DuraDiagnost (R2.0, Product Number 712211)  DuraDiagnost (R3.0, Product Number 712211)
Tube arm assembly could fall down due to cracked welding joints
Blood products, in which donor suitability was not adequately determined, were distributed.
Blood and Blood Products for Reprocessing
Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93
Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities
Worldwide Distribution - US (Nationwide)  OUS:   CANADA  ARGENTINA  AUSTRALIA  AUSTRIA  BAHRAIN  BELGIUM  BRAZIL  CHILE  CHINA  COLOMBIA  CZECH REPUBLIC  FINLAND  FRANCE  GERMANY  GREECE  INDIA  INDONESIA  IRELAND  ITALY  JAPAN  KENYA  KOREA, REPUBLIC OF  NETHERLANDS  PHILIPPINES  POLAND  SPAIN  SWEDEN  SWITZERLAND  THAILAND  TURKEY  UNITED KINGDOM
M3150 Information Center Local Database; Models: 862249, 865001, 865003, 865004, 865007, 865009, 865011, 865012, 865091, 865092, 865093, 865094, 865095, 865096, 865098, 865099, 865102, 865104, 865105, 865125, 865127.  The intended use of the Information Center Software is to display physiologic waves, parameters and trends, formal data for strip recordings and printed reports and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors
This action affects certain customers who were shipped an affected Philips Intellivue Information Center unit between  June 9, 2008 and May 31, 2009.  Affected products have a PC serial number range between 2UA8300XYZ and 2UA84510QW.  However, only a subset of these products are affected.
Domestic only: ASSOCIATED FOODS STORES   FARR WEST WAREHOUSE  1850 WEST 2530 NORTH   FARR WEST, UT  84404
Western Family Onion Soup Mix, 2.25 oz. pouches packaged in 4.5-oz. cartons
Western Family Onion Soup Mix, UPC 15400-03604,  2.25 oz. pouches packaged in 4.5-oz. cartons which have a Best By date of APR 10 18 D16
Blood product collected from donors who lived in malarial endemic areas, was distributed.
ESTRONE USP, packaged in a) 1g bottle (NDC: 58597-8049-2), c) 5g bottle (NDC: 58597-8049-3), d) 25g bottle (NDC: 58597-8049-4), For Prescription Compounding, RX Only, Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC, 6650 Highland Road, Waterford, MI 48327
cGMP Deviations; lack of quality assurance.