June 2017 recalls

758 recalls were announced in June 2017.

What the numbers show

Critical: 27
Severe: 142
High: 261
Moderate: 293
Low: 35

Of the 758 recalls this month scored against our rubric, 4% are Critical, 19% are Severe.

Which agencies issued them

401–500 of 758

ModerateFDA (Devices)·Z-2411-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, leading to antibiotic degradation and loss of potency.
Product
VITEK¿ 2 Gram Negative Susceptibility card (AST-N238), REF 413203, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2335-2017·2017-06-21
Arrow International Recalls Two-Lumen Central Venous Access Kits
Arrow International is recalling Two-Lumen Central Venous Access Kits because packaging may not be completely sealed, potentially compromising sterility.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2558-2017·2017-06-21
Zimmer Biomet Recalls Sterile Femoral Intramedullary Nail Implants
Zimmer Biomet is recalling sterile femoral intramedullary nail implants due to packaging design verification test failures.
Product
Fem IM Nail 16mmdx48cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2376-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised container integrity may expose the product to moisture, potentially degrading antibiotic potency.
Product
VITEK¿ 2 Gram Positive Susceptibility card (AST-P618), REF 410806, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2367-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards Due to Moisture Risk
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because container integrity may be compromised, allowing moisture exposure that could degrade antibiotic potency.
Product
VITEK¿ 2 Gram Positive Susceptibility card (AST-P607), REF 22335, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2363-2017·2017-06-21
Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards
Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because container integrity issues may expose the product to moisture, potentially causing antibiotic degradation.
Product
VITEK¿ 2 Gram Positive Susceptibility card (AST-P603), REF 22320, 20 cards per carton.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2539-2017·2017-06-21
Cook Multi-Use Holmium Laser Fibers Recalled for Reprocessing Instruction Deficiencies
Cook Inc. is recalling 4,369 multi-use holmium laser fibers because the current instructions for use do not provide sufficient detail for proper cleaning, disinfection, and sterilization.
Product
Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages
Category
Medical Device
Distribution
31 states
LowFDA (Drugs)·D-0911-2017·2017-06-21
Pharmedium Recalls Potassium Phosphate IV Bags Due to Incorrect Volume Labeling
Pharmedium Services, LLC is recalling 672 bags of Potassium Phosphate IV solution because the printed volume on the label is incorrect.
Product
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
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0912-2017·2017-06-21
Pharmedium Recalls Potassium Phosphate IV Bags Due to Labeling Error
Pharmedium Services is recalling 48 bags of Potassium Phosphate IV solution because the printed volume on the label is incorrect.
Product
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
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0913-2017·2017-06-21
Pharmedium Recalls IV Bags with Incorrect Volume Labeling
Pharmedium Services, LLC is recalling 216 bags of Potassium Phosphate in 0.9% Sodium Chloride because the total volume was incorrectly printed on the label.
Product
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
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2587-2017·2017-06-21
Teleflex Recalls Sheridan Intubating Stylets Due to Incorrect Size Labeling
Teleflex Medical is recalling Sheridan SHER-I-SLIP and SOFT-TIP Intubating Stylets because the product size listed on the labeling is incorrect.
Product
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 sh
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0920-2017·2017-06-21
Mylan Recalls Montelukast Sodium Oral Granules Due to Impurity Failures
Mylan Pharmaceuticals is recalling 11,624 pouches of Montelukast Sodium Oral Granules, 4 mg, due to failed impurity specifications.
Product
Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0906-2017·2017-06-21
Pharmedium Recalls 216 Bags of Potassium Chloride with Incorrect Volume Labeling
Pharmedium Services, LLC is recalling 216 bags of Potassium Chloride in 0.9% Sodium Chloride because the product labels incorrectly state a volume of 115.00 mL instead of the actual 100.00 mL.
Product
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
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0907-2017·2017-06-21
Pharmedium Recalls Potassium Chloride Bags With Incorrect Volume Labeling
Pharmedium Services, LLC is recalling 143 bags of Potassium Chloride in 0.9% Sodium Chloride because the product label incorrectly states the total volume as 105.00 mL instead of 100.00 mL.
Product
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
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0909-2017·2017-06-21
Pharmedium Recalls IV Bags With Incorrect Volume Labeling
Pharmedium Services, LLC is recalling 192 bags of Potassium Phosphate IV solution because the printed volume on the label is incorrect.
Product
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
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0910-2017·2017-06-21
Pharmedium Recalls IV Bags With Incorrect Volume Labeling
Pharmedium Services, LLC is recalling 912 bags of Potassium Phosphate IV solution because the printed volume on the label is incorrect.
Product
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
Category
Drug
Distribution
Distributed nationwide
CriticalUSDA FSIS·073-2017-EXP·2017-06-20
Channel Fish Processing Recalls Breaded Swai Fillets Due to Undeclared Milk
Channel Fish Processing Co., Inc. is recalling approximately 1,190 pounds of breaded Swai products because they may contain undeclared milk, a known allergen.
Product
Channel Fish Processing Co., Inc. — Channel Fish Processing Co., Inc. Recalls Siluriformes Fish Products Due To Misbranding and Undeclared Allergens
Category
Food
Distribution
1 state
SevereNHTSA·17V388000·2017-06-20
KTM Recalls 2016-2017 690 Duke Motorcycles for Fuel Leak Risk
KTM is recalling 2016-2017 690 Duke motorcycles because the fuel tank filler cap area may leak, increasing the risk of fire or injury.
Product
KTM — KTM 690 DUKE
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·17E029000·2017-06-20
Cummins Recalls X15 Diesel Engines Due to Fuel Pump Gear Slip
Cummins is recalling X15 heavy-duty diesel engines because a fuel pump drive gear may slip, causing engine stalls and increasing crash risk.
Product
FUEL SYSTEM, DIESEL recall
Category
Vehicle
Distribution
Distributed nationwide
SevereUSDA FSIS·074-2017-EXP·2017-06-20
Embutidos Fanguito Recalls Pork Products for Mislabeling and Undeclared Allergens
Embutidos Fanguito, Inc. is recalling pork products due to mislabeling, misbranding, and undeclared allergens. The products were distributed to retail locations in Florida.
Product
Embutidos Fanguito Inc. — Embutidos Fanguito, Inc. Recalls Pork Products Due To Mislabeling, Misbranding, and Undeclared Allergens
Category
Food
Distribution
1 state
HighCPSC·17180·2017-06-20
Staples Recalls Hazen Mesh Task Chairs Due to Fall Hazard
Staples is recalling Hazen Mesh Task chairs because the legs can break, posing a fall hazard. Consumers should stop using the chairs and contact Staples for a free replacement base.
Product
Hazen Mesh Task chairs
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·17751·2017-06-20
Kawasaki Recalls Utility and Off-Highway Vehicles Due to Fire Hazard
Kawasaki is recalling approximately 6,600 utility, recreational off-highway, and all-terrain vehicles because a fuel gauge retainer can collapse and leak fuel, posing a fire hazard.
Product
Utility vehicles, recreational off-highway vehicles and all-terrain vehicles
Category
Vehicle
Distribution
Distributed nationwide
LowNHTSA·17V387000·2017-06-20
KZRV Recalls 2018 Recreational Trailers Due to Missing Certification Date
KZRV is recalling 2018 recreational trailers because the Federal Certification label lacks the manufacturing date, potentially preventing owners from identifying other safety recalls.
Product
KZRV — KZRV VENOM, SPORTSMEN SPORTSTER, SPREE, SPORT TREK
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·17V384000·2017-06-19
Entegra Recalls 2012-2015 Cornerstone Motorhomes Due to Starter Fire Risk
Entegra is recalling 2012-2015 Cornerstone motorhomes because a starter motor component may break, causing overheating and increasing the risk of a fire.
Product
ENTEGRA — ENTEGRA CORNERSTONE
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·17V383000·2017-06-19
Triple E RV Recalls 2016-2017 Wonder Motorhomes Due to Frame Bolt Defect
Triple E RV is recalling 2016-2017 Wonder motorhomes because missing frame bolts may cause structural distortion and affect vehicle control.
Product
TRIPLE E RV — TRIPLE E RV WONDER
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·17V385000·2017-06-19
Starcraft RV Recalls 2018 Launch Outfitter Trailers for Electrical Outlet Defect
Starcraft RV is recalling 2018 Launch Outfitter travel trailers because an electrical outlet lacks Ground Fault Circuit Interrupter protection, increasing the risk of electrical shock.
Product
STARCRAFT RV TT — STARCRAFT RV TT LAUNCH OUTFITTER
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·17V386000·2017-06-19
BYD Recalls 2015-2016 K7 M Buses for Wiper Arm Defect
BYD is recalling 2015-2016 K7 M buses because wiper arms may crack and detach, reducing visibility and increasing crash risk.
Product
BYD — BYD K7 M
Category
Vehicle
Distribution
Distributed nationwide
HighUSDA FSIS·075-2017·2017-06-17
Supreme Cuisine Recalls Meat and Poultry Fat Products Due to Processing Deviation
Supreme Cuisine is recalling approximately 325,000 pounds of meat and poultry fat and lard products due to a processing deviation that may allow bacterial pathogens to grow.
Product
Supreme Cuisine Recalls Meat and Poultry Fat and Lard Products Due to Processing Deviation
Category
Food
Distribution
Distributed nationwide
CriticalUSDA FSIS·073-2017·2017-06-16
Channel Fish Processing Recalls Breaded Swai Fillets Due to Undeclared Milk
Channel Fish Processing Co. is recalling approximately 840 pounds of breaded Swai fillets because they may contain undeclared milk, a known allergen.
Product
Channel Fish Processing Co., Inc. — Channel Fish Processing Co., Inc. Recalls Siluriformes Fish Products Due to Misbranding and Undeclared Allergens
Category
Food
Distribution
1 state
SevereUSDA FSIS·074-2017·2017-06-16
Embutidos Fanguito Recalls Pork Ham Due to Mislabeling and Allergens
Embutidos Fanguito, Inc. is recalling approximately 454 pounds of sliced pork ham products due to mislabeling, misbranding, and undeclared allergens.
Product
Embutidos Fanguito Inc. — Embutidos Fanguito, Inc. Recalls Pork Products Due to Mislabeling, Misbranding, and Undeclared Allergens
Category
Food
Distribution
1 state
HighCPSC·17750·2017-06-16
Advanced Composites Recalls Bicycle Forks Due to Fall Hazard
Advanced Composites is recalling about 40 Wound Up Tandem Duo Disc bicycle forks because the fork leg can crack, posing a fall hazard.
Product
Bicycle forks
Category
Consumer Product
Distribution
Distributed nationwide
SevereNHTSA·17V381000·2017-06-15
Thor Motor Coach Recalls 2018 Outlaw 29H Motorhomes for Fire Risk
Thor Motor Coach is recalling 2018 Outlaw 29H motorhomes because an incorrect fuse size may increase the risk of a fire if the awning light circuit short circuits.
Product
THOR MOTOR COACH — THOR MOTOR COACH OUTLAW
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·17749·2017-06-15
iFashioning Recalls Women's Scarves for Flammability Standard Violation
iFashioning is recalling about 2,000 women's scarves sold on Amazon.com because they fail to meet federal flammability standards, posing a risk of burn injuries.
Product
Women's scarves
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·17178·2017-06-15
Little Giraffe Recalls Children's Satin Robes for Flammability Violations
Little Giraffe is recalling about 2,000 Luxe Satin children's robes because they fail federal flammability standards, posing a burn risk.
Product
Luxe Satin children's robes
Category
Consumer Product
Distribution
Distributed nationwide
HighNHTSA·17C002000·2017-06-15
Britax Recalls B-Safe 35 Infant Car Seats Due to Chest Clip Defect
Britax is recalling specific B-Safe 35 infant car seats because a tab on the chest clip may break, creating a choking hazard.
Product
CHILD SEAT:HARNESS RETAINER/CHEST CLIP recall
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·17V382000·2017-06-15
GM Recalls 2014-2016 Chevrolet SS Vehicles for Steering Defect
General Motors is recalling 2014-2016 Chevrolet SS vehicles because corrosion may cause a loss of electric power steering assist, increasing crash risk.
Product
CHEVROLET — CHEVROLET CHEVEROLET SS
Category
Vehicle
Distribution
Distributed nationwide
CriticalFDA (Food)·F-2329-2017·2017-06-14
Hilo Fish Company Recalls Frozen Yellowfin Tuna Cubes for Hepatitis A
Hilo Fish Company Inc. is recalling 199 cases of frozen yellowfin tuna cubes after independent lab testing found positive results for Hepatitis A.
Product
Frozen Yellowfin tuna cubes, random; Individually vacuum packed; 15 lb. case. Product of the Philippines; Brand - Krimson Product; UPC 10664183002946 Ingredient: - Frozen Tuna and tasteless smoke - to promote color retention. Imported by Hilo Fish Company Inc., Hono
Category
Food
Distribution
2 states
CriticalFDA (Food)·F-2330-2017·2017-06-14
Hilo Fish Company Recalls Tuna Steaks Due to Hepatitis A
Hilo Fish Company is recalling Krimson Brand Tuna Steaks after independent lab testing found positive results for Hepatitis A.
Product
Tuna Steaks, 8 oz. individually vacuum packed bags; Krimson Brand, Product of Vietnam; 10 lb. cases; Ingredients: frozen tuna and tasteless smoke to promote color retention. UPC: 10664183000751
Category
Food
Distribution
2 states
CriticalUSDA FSIS·072-2017·2017-06-14
Golden Platter Foods Recalls Poultry and Beef Products for Undeclared Milk
Golden Platter Foods Inc. is recalling approximately 31,662 pounds of ready-to-eat poultry and beef products due to misbranding and undeclared milk, a known allergen.
Product
Golden Platter Foods Inc. — Golden Platter Foods Inc. Recalls Poultry and Beef Products
Category
Food
Distribution
4 states
SevereFDA (Devices)·Z-2273-2017·2017-06-14
Arrow International Recalls Central Venous Catheter Kits Due to Needlestick Risk
Arrow International is recalling specific central venous catheter kits because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.
Product
Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2268-2017·2017-06-14
Arrow Pressure Injectable PICC Kit Recalled for Needlestick Injury Risk
Arrow International is recalling 43,394 units of Pressure Injectable PICC Kits due to safety cover disengagement and needlestick injury reports.
Product
Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2256-2017·2017-06-14
Arrow International Recalls Pressure Injectable PICC Kits Due to Needlestick Risk
Arrow International is recalling Pressure Injectable PICC Kits because the packaged BD Eclipse Needle has a safety cover that may disengage, posing a needlestick injury risk.
Product
Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2266-2017·2017-06-14
Arrow PICC Recall Initiated Due to Needlestick Injury Risk
Arrow International is recalling 43,394 units of Arrow PICC with Chlorag+ard Technology due to safety cover disengagement and needlestick injury risks associated with packaged BD Eclipse Needles.
Product
Arrow PICC with Chlorag+ard Technology A PICC permits venous access to the central circulation through a peripheral vein
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-2270-2017·2017-06-14
High Liner Foods Breaded Haddock Recalled for Undeclared Milk
ISF "USA", LLC is recalling High Liner Foods Breaded Haddock Tail Portions due to undeclared milk, a major allergen.
Product
High Liner Foods, Breaded Haddock Tail Portions 5 oz.
Category
Food
Distribution
0 states
SevereFDA (Devices)·Z-2297-2017·2017-06-14
Arrow Radial Artery Catheterization Kit Recalled for Needlestick Injury Risk
Arrow International is recalling Radial Artery Catheterization Kits because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.
Product
Radial Artery Catheterization Kit with Sharps Safety Features The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2296-2017·2017-06-14
Arrow Radial Artery Catheterization Kit Recalled for Needlestick Injury Risk
Arrow International is recalling Radial Artery Catheterization Kits because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.
Product
Radial Artery Catheterization Kit with Sharps Safety Features The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2293-2017·2017-06-14
Arrow Percutaneous Sheath Introducer Kit Recalled for Needlestick Injury Risk
Arrow International is recalling specific Percutaneous Sheath Introducer Kits due to reports of safety cover disengagement and needlestick injuries associated with packaged BD Eclipse Needles.
Product
Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7 - 7.5¿¿Fr. Catheters The Arrow Percutaneous Sheath Introducer permits venous access and catheter introduction to the central ciruclation
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2254-2017·2017-06-14
Arrow International Recalls Central Venous Access Kits Due to Needlestick Risk
Arrow International is recalling specific central venous access kits because the packaged BD Eclipse Needle has a safety cover that may disengage, posing a needlestick injury risk.
Product
ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter introduction to the central circulation. It may be inserted into the
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0890-2017·2017-06-14
Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations
Qualgen is recalling Estradiol 22 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 1,666 pellets distributed nationwide.
Product
Estradiol 22 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC 69761-022-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2304-2017·2017-06-14
Arrow Percutaneous Sheath Introducer Kit Recalled for Needlestick Injury Risk
Arrow International is recalling Percutaneous Sheath Introducer Kits due to reports of safety cover disengagement and needlestick injuries associated with packaged BD Eclipse Needles.
Product
Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5-8 Fr. Catheters The Arrow¿ Percutaneous Sheath Introducer permits venous access and catheter introduc
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2279-2017·2017-06-14
Arrow International Recalls CVC Kits Due to Needlestick Injury Risk
Arrow International is recalling specific CVC kits because the packaged BD Eclipse Needle may disengage, posing a needlestick injury risk to medical personnel.
Product
AGB+ Pressure Injectable Multi-Lumen CVC Kit The Arrow Central Venous Catheters are intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins.The ARROWg+ard Blue¿ Catheter permits venous access to the central circulation by wa
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2300-2017·2017-06-14
Arrow Arterial Catheterization Kit Recalled for Needlestick Injury Risk
Arrow International is recalling Arterial Catheterization Kits due to reports of safety cover disengagement and needlestick injuries associated with packaged BD Eclipse Needles.
Product
Arterial Catheterization Kit The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0882-2017·2017-06-14
Spectrum Chemical Recalls Levonorgestrel API Due to CGMP Deviations
Spectrum Laboratory Products is recalling levonorgestrel active pharmaceutical ingredient due to manufacturing deviations found by the FDA.
Product
Levonorgestrel, U.S.P. active pharmaceutical ingredient, packaged in 1 kg container, Rx only, Spectrum Chemical Mfg. Corp, Gardena, CA 90248, New Brunswick, NJ 08901, Product code L1229.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2286-2017·2017-06-14
Arrow PICC Recall Due to Safety Cover Disengagement and Needlestick Risk
Arrow International is recalling Arrow PICC devices with Chlorag+ard Technology because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.
Product
Arrow PICC with Chlorag+ard Technology The ArrowEVOLUTION 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, infu
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2295-2017·2017-06-14
Arrow International Recalls Femoral Arterial Line Catheterization Kits
Arrow International is recalling specific femoral arterial line catheterization kits due to reports of safety cover disengagement and needlestick injuries associated with packaged BD Eclipse Needles.
Product
Femoral Arterial Line Catheterization Kit The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2265-2017·2017-06-14
Arrow International Recalls Large-Bore CVC Kits Due to Needlestick Risk
Arrow International is recalling 43,394 units of ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kits nationwide due to safety cover disengagement and needlestick injury risks associated with packaged BD Eclipse Needles.
Product
ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid fluid administration
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2253-2017·2017-06-14
Arrow International Recalls Central Venous Access Kits Due to Needlestick Risk
Arrow International is recalling MAC Two-Lumen Central Venous Access Kits because packaged BD Eclipse Needles may disengage, posing a needlestick injury risk.
Product
MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) pe
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2290-2017·2017-06-14
Arrow International Recalls Access Kits Due to Needlestick Injury Risk
Arrow International is recalling specific Access Kits because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.
Product
Arrow¿ Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally Inserted Central Venous Catheter The Arrow¿ GlideThru" Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduction of diagnostic or therapuetic devices into the vasculature
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2302-2017·2017-06-14
Arrow Arterial Line Kits Recalled for Needlestick Injury Risk
Arrow International is recalling Arterial Line Kits because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.
Product
Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2299-2017·2017-06-14
Arrow Arterial Catheterization Kits Recalled for Needlestick Injury Risk
Arrow International is recalling Arterial Catheterization Kits due to reports of safety cover disengagement and needlestick injuries associated with packaged BD Eclipse Needles.
Product
Arterial Catheterization Kit with Maximal Barrier Precautions The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-2335-2017·2017-06-14
Still Riding Foods Recalls Gluten-Free Pizza Crust Due to Botulism Risk
Still Riding Foods is recalling gluten-free pizza crust due to a C. botulinum hazard in vacuum-packed products. The recall covers 1,555 cases distributed across 23 states.
Product
STILL RIDING FOODS GLUTEN FREE PIZZA CRUST; Sold in the following package sizes: 36/9" NET WT 15lbs (6.80kg); 12/12" NET WT 10lbs (5.44kg); 24/12" NET WT 27lbs (12.25kg); 18/9" NET WT 7lbs (3.18kg)
Category
Food
Distribution
24 states
SevereFDA (Devices)·Z-2292-2017·2017-06-14
Arrow International Recalls Central Catheters Due to Needlestick Injury Risk
Arrow International is recalling specific central catheters because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.
Product
"Pressure Injectable Jugular Axillo-Subclavian Central Catheter (JACC) Product" The CG+ Arrow JACC powered by Arrow VPS Stylet permits venous access to the central circulation through a central vein. The VPS Stylet, used with the VPS Console, quickly and accurately guides the
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-2271-2017·2017-06-14
High Liner Foods Recalls Lightly Breaded Cod Tail Portions for Undeclared Milk
ISF "USA", LLC is recalling High Liner Foods Lightly Breaded Cod Tail Portions due to undeclared milk. The recall affects 2,244 cases distributed within the United States.
Product
High Liner Foods, Lightly Breaded Cod Tail Portions 4 oz. and 5 oz
Category
Food
Distribution
0 states
SevereFDA (Devices)·Z-2260-2017·2017-06-14
Arrow International Recalls Hemodialysis Catheter Kits Due to Needlestick Risk
Arrow International is recalling 43,394 hemodialysis catheterization kits nationwide because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.
Product
Two-Lumen Hemodialysis Catheterization Kit with Blue Flex Tip(R), ARROWg+ard Blue(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions for High Volume Infusions. The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2278-2017·2017-06-14
Arrow International Recalls Multi-Lumen CVC Kits Due to Needlestick Risk
Arrow International is recalling specific multi-lumen central venous catheter kits because packaged BD Eclipse Needles may disengage, posing a needlestick injury risk.
Product
AGB+ Pressure Injectable Multi-Lumen CVC Kit intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-2333-2017·2017-06-14
Krisppee Batter Mix Recalled for Undeclared Milk Allergen
Krisppee Products Co. is recalling Krisppee Batter Mix for Fish & Chips due to undeclared milk. The product was distributed in Rhode Island and Massachusetts.
Product
KRISPPE BATTER MIX For FISH & CHIPS Net WEIGHT 5 lbs., 25 lbs., 50 lbs.
Category
Food
Distribution
2 states
SevereFDA (Devices)·Z-2172-2017·2017-06-14
Laserex Systems Recalls Ellex Tango Reflex Laser Ophthalmic Units
Laserex Systems Inc. is recalling 83 Ellex Tango Reflex laser ophthalmic units because they may emit laser energy without the fire button being pressed.
Product
Ellex Tango Reflex with slit lamp Laser Ophthalmic In the SLT mode, the device is intended to be used for selective laser trabeculoplasty (ST) operations (laser trabeculoplasty for primary open angle glaucoma). In the VAG mode it is intended to be used to perform procedures r
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2261-2017·2017-06-14
Arrow Percutaneous Sheath Introducer Kit Recalled for Needlestick Injury Risk
Arrow International is recalling Percutaneous Sheath Introducer Kits due to reports of safety cover disengagement and needlestick injuries associated with packaged BD Eclipse Needles.
Product
Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostatis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5-8 Fr. Catheters. The Arrow Percutaneous Sheath Introducer permits venous access and catheter introducti
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2269-2017·2017-06-14
Arrow Pressure Injectable PICC Kit Recalled for Needlestick Injury Risk
Arrow International is recalling 43,394 units of Pressure Injectable PICC Kits nationwide due to reports of safety cover disengagement and needlestick injuries.
Product
Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2321-2017·2017-06-14
OrthoPediatrics Recalls Response BandLoc Tensioner Instruments Due to Band Rupture Risk
OrthoPediatrics Corp is recalling 82 Response BandLoc 5.5/6.0 Tensioner Instruments because over-tensioning can damage the band, causing it to rupture during spine surgery.
Product
Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-1102-1000) is utilized to allow the surgeon to apply a recommended tension to the band and hold it in place during spine manipulation and set screw tightening.
Category
Medical Device
Distribution
6 states
SevereFDA (Devices)·Z-2281-2017·2017-06-14
Arrow VPS Access Kit Recalled Due to Needlestick Injury Risk
Arrow International is recalling VPS Access Kits because packaged BD Eclipse Needles may disengage, posing a needlestick injury risk.
Product
Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters (PICCs) to the goal location which
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2301-2017·2017-06-14
Arrow QuickFlash Radial Artery Catheterization Kit Recalled for Needlestick Risk
Arrow International is recalling QuickFlash Radial Artery Catheterization Kits because the packaged BD Eclipse Needle may disengage, posing a needlestick injury risk.
Product
QuickFlash(R) Radial Artery/Arterial Line Catheterization Kit The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2288-2017·2017-06-14
Arrow Access Kit Recalled Due to Needlestick Injury Risk
Arrow International is recalling specific Access Kits because the packaged BD Eclipse Needle may disengage, posing a needlestick injury risk.
Product
Arrow(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The Arrow¿ GlideThru" Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduction of diagnostic or therapuetic devices into the vasculature.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2246-2017·2017-06-14
Baxter MiniCap PD Transfer Set Recalled for Connection Leak Risk
Baxter Healthcare is recalling MiniCap Extended Life PD Transfer Sets because connection issues may cause leaks and contamination, potentially leading to peritonitis.
Product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short. 1 Unit. Sterile. Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2276-2017·2017-06-14
Arrow Catheter Kits Recalled for Needlestick Injury Risk
Arrow International is recalling catheterization kits because the packaged BD Eclipse Needle has a safety cover that can disengage, causing needlestick injuries.
Product
Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features, and Maximal Barrier Precautions The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatme
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2264-2017·2017-06-14
Arrow International Recalls Central Venous Access Kits Due to Needlestick Risk
Arrow International is recalling 43,394 central venous access kits because the packaged BD Eclipse Needle has a safety cover that may disengage, posing a needlestick injury risk.
Product
ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit. The MAC Two-Lumen Central Venous Access Device with ARROWg+ard Blue permits venous access and catheter introduction to the central circulation
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2272-2017·2017-06-14
Arrow Central Venous Catheter Kits Recalled for Needlestick Injury Risk
Arrow International is recalling certain central venous catheter kits because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.
Product
Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment of diseases or conditions r
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2284-2017·2017-06-14
Arrow VPS Access Kit Recalled for Needlestick Injury Risk
Arrow International is recalling VPS Access Kits due to reports of safety cover disengagement and needlestick injuries associated with packaged BD Eclipse Needles.
Product
Arrow(R) VPS(R) Access Kit for use with 5 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters (PICCs) to the goal location wh
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2289-2017·2017-06-14
Arrow Access Kit Recalled Due to Needlestick Injury Risk
Arrow International is recalling specific Access Kits because packaged BD Eclipse Needles may disengage, posing a needlestick injury risk.
Product
Arrow¿ Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally Inserted Central Venous Catheter The Arrow¿ GlideThru" Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduction of diagnostic or therapuetic devices into the vasculature
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2291-2017·2017-06-14
Arrow PICC Recall Initiated Due to Safety Cover Disengagement and Needlestick Injury
Arrow International is recalling Arrow PICC products with Chlorag+ard Technology due to reports of safety cover disengagement and needlestick injuries associated with packaged BD Eclipse Needles.
Product
Arrow PICC with Chlorag+ard Technology A PICC permits venous access to the central circulation through a peripheral vein. The intended use of the VP'S Stylet and Console (VPS System) is to quickly and accurately guide market available central catheters to the desired location wh
Category
Medical Device
Distribution
Distributed nationwide
SevereNHTSA·17V377000·2017-06-14
BMW Recalls 2017-2018 M760Li Vehicles for Engine Oil Cooler Line Defect
BMW is recalling 2017-2018 M760Li xDrive vehicles because an incorrect engine oil cooler line may cause an oil leak that increases crash risk.
Product
BMW — BMW M760LI
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2283-2017·2017-06-14
Arrow VPS Access Kit Recalled for Needlestick Injury Risk
Arrow International is recalling VPS Access Kits because packaged BD Eclipse Needles may disengage, posing a needlestick injury risk.
Product
Arrow¿ VPS¿ Access Kit with Maximal Barrier Precautions for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters (P
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2257-2017·2017-06-14
Arrow VPS Access Kit Recalled for Needlestick Injury Risk
Arrow International is recalling VPS Access Kits due to safety cover disengagement on packaged BD Eclipse Needles, posing a needlestick injury risk.
Product
Arrow VPS Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally inserted Central Venous Catheter The Arrow(r) CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access inc
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2282-2017·2017-06-14
Arrow VPS Access Kit Recalled for Needlestick Injury Risk
Arrow International is recalling VPS Access Kits because packaged BD Eclipse Needles may disengage, posing a needlestick injury risk.
Product
Arrow¿ VPS¿ Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters (PIC
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2275-2017·2017-06-14
Arrow Central Venous Catheter Kits Recalled for Needlestick Injury Risk
Arrow International is recalling specific central venous catheter kits because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.
Product
Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment of diseases or conditions requiring central venous acces
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-2274-2017·2017-06-14
ISF USA Recalls Raw Breaded Alaska Pollock Portions for Undeclared Milk
ISF "USA", LLC is recalling 1,581 cases of FPI Crunchy Lites Raw Breaded Alaska Pollock Portions due to undeclared milk.
Product
FPI, Crunchy Lites Raw Breaded Alaska Pollock Portions 3.6 oz
Category
Food
Distribution
0 states
SevereFDA (Devices)·Z-2248-2017·2017-06-14
Stryker Recalls Berchtold Chromophare F300 Exam Lights Due to Mounting Defect
Stryker Communications is recalling 57 Berchtold Chromophare F300 exam lights because a tolerance issue may cause the equipment to fall, posing a risk of serious injury.
Product
Berchtold Chromophare F300 Exam Light CHROMOPHARE examination lights are medical lights used for local illumination of the patients' body so that illnesses, injuries and disabilities can be diagnosed and treated
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2270-2017·2017-06-14
Arrow International Recalls CVC Kits Due to Needlestick Injury Risk
Arrow International is recalling ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kits because packaged BD Eclipse Needles may disengage, posing a needlestick injury risk.
Product
ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit. The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid fluid administration. It ma be inserted into the jugular, subclavian or femoral veins
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2285-2017·2017-06-14
Arrow PICC Kit Recalled Due to BD Eclipse Needle Safety Cover Issues
Arrow International is recalling certain PICC kits because the packaged BD Eclipse Needle has a safety cover that may disengage, posing a needlestick injury risk.
Product
Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The ArrowEVOLUTIONTM Pressure Injectable P1CC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral access to the central venous system for intrave
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2267-2017·2017-06-14
Arrow International Recalls Central Catheters Due to Needlestick Injury Risk
Arrow International is recalling 43,394 units of central catheters because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.
Product
Pressure injectable Jugular Axillo-Subclavian Central CThe CG+Arrow JACC powered by Arrow VPS Stylet permits venous access to the central circulation through a central veinatheter (JACC) Product
Category
Medical Device
Distribution
Distributed nationwide
SevereNHTSA·17V380000·2017-06-14
Piaggio Recalls 2016-2017 Moto Guzzi Motorcycles for Brake Hose Defect
Piaggio is recalling 2016-2017 Moto Guzzi motorcycles because the front ABS brake hose may rub against the engine, causing a fluid leak that increases crash risk.
Product
PIAGGIO — PIAGGIO, MOTO GUZZI V7 III SPECIAL 750, MOTO GUZZI V7 III RACER 7, V9 BOBBER, V7 III STONE 750
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2259-2017·2017-06-14
Arrow International Recalls Central Venous Access Kits Due to Needlestick Risk
Arrow International is recalling 43,394 units of MAC Two-Lumen Central Venous Access Kits because packaged BD Eclipse Needles may disengage, posing a needlestick injury risk.
Product
MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue (R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 -8 Fr. Catheters. The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) p
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0888-2017·2017-06-14
MedPark Pharmacy Recalls Methylcobalamin Injection Vials Due to Sterility Concerns
MedPark Pharmacy is recalling methylcobalamin 1mg/1mL injection vials because the company cannot ensure the product is sterile. The affected lot was distributed to a patient in Maryland.
Product
methylcobalamin 1mg/1mL, vial for injection, Rx only, MedPark Pharmacy 2002 Medical Pkwy. # 170 Annapolis, MD 21401
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0894-2017·2017-06-14
Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations
Qualgen is recalling Estradiol 12.5 mg pellets due to CGMP deviations and a lack of quality assurance. The recall covers 4,883 pellets distributed nationwide.
Product
Estradiol 12.5 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013, NDC: 69761-012-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2287-2017·2017-06-14
Arrow International Recalls Access Kits Due to Needlestick Injury Risk
Arrow International is recalling Access Kits with Maximal Barrier Precautions because packaged BD Eclipse Needles may disengage, posing a needlestick injury risk.
Product
Arrow¿ Access Kit with Maximal Barrier Precautions for use with 4 Fr. Peripherally Inserted Central Venous Catheter The Arrow¿ GlideThru" Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduction of diagnostic or therapuetic devices into the vasculature.
Category
Medical Device
Distribution
Distributed nationwide
SevereNHTSA·17V378000·2017-06-14
Newmar Recalls 2012-2015 Motorhomes Due to Starter Motor Fire Risk
Newmar is recalling 2012-2015 King Aire and Essex motorhomes because a starter motor component may break, causing overheating and increasing the risk of a fire.
Product
NEWMAR — NEWMAR ESSEX, KING AIRE
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2230-2017·2017-06-14
ConvaTec Recalls Non-Rebreathing Masks and Reservoir Bags Due to Valve Defect
ConvaTec, Inc. is voluntarily recalling specific lots of non-rebreathing masks and reservoir bags because the check valves may fail to function correctly.
Product
Non-Rebreathing Mask, Reservoir Bag, Check Valve, One Side Valve, with Tubing, Product Code 106-E, Product Code 3226MM, and Product Code 9108MM
Category
Medical Device
Distribution
14 states
HighFDA (Food)·F-2332-2017·2017-06-14
Krisppee Clam Cake Mix Recalled for Undeclared Milk Allergen
Krisppee Products Co. is recalling Famous Rhode Island Clam Cake Mix in 5, 25, and 50 lb sizes because it contains undeclared milk.
Product
KRISPPE FAMOUS RHODE ISLAND CLAM CAKE MIX NET WEIGHT 5 lbs., 25 lbs., 50 lbs.
Category
Food
Distribution
2 states
HighFDA (Devices)·Z-2225-2017·2017-06-14
Magellan LeadCare Blood Lead Test Kits Recalled for Underestimating Results
Magellan Diagnostics is recalling LeadCare and LeadCare II test kits because they may underestimate lead concentrations in venous blood samples.
Product
Magellan Diagnostics LeadCare and LeadCare II test Kits. Product Usage: The LeadCare Blood Lead Test Kit is for in vitro diagnostic use only. The Test Kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sensors and
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-2273-2017·2017-06-14
Viking Breaded Flounder Fillets Recalled for Undeclared Milk
ISF "USA", LLC is recalling Viking Breaded Natural Flounder Fillets due to undeclared milk. The recall affects 263 cases distributed within the United States.
Product
Viking, Breaded Natural Flounder Fillets 4 oz.
Category
Food
Distribution
0 states

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