États-Unis Recalls
Rappels de sécurité de la FDA, CPSC, NHTSA et de l’USDA FSIS.
FDA DevicesMedtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter
Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter
Certain lots of product have the potential for a sterile barrier breach.
FDA DevicesAllura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);
Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.
FDA DevicesSwan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P
Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
FDA FoodGHIRARDELLI PERFECTLY PREMIUM FRAPPE MIX CLASSIC WHITE NET WT 50oz (3lbs 2oz) 1.42kg Ingredients: *** nonfat dry milk *** GHIRARDELLI PERFECTLY PREMIUM FRAPPE MIX CLASSIC WHITE NET WT 10lbs (4.54kg) Ingredients: *** nonfat dry milk *** GHIRARDELLI PERFECTLY PREMIUM FRAPPE MIX CLASSIC WHITE NET WT 30LB (13.62kg) Ingredients: *** nonfat dry milk *** Distributed by Ghirardelli Chocolate Company, San Leandro, CA 94578, U.S.A. UPC (50oz): 747599662010 UPC (10lbs): 747599662034 UPC (30lbs): 747599419027
GHIRARDELLI PERFECTLY PREMIUM FRAPPE MIX CLASSIC WHITE NET WT 50oz (3lbs 2oz) 1.42kg Ingredients: *** nonfat dry milk *** GHIRARDELLI PERFECTLY PREMIUM FRAPPE MIX CLASSIC WHITE NET WT 10lbs (4.54kg) Ingredients: *** nonfat dry milk *** GHIRARDELLI PERFECTLY PREMIUM FRAPPE MIX CLASSIC WHITE NET WT 30LB (13.62kg) Ingredients: *** nonfat dry milk *** Distributed by Ghirardelli Chocolate Company, San Leandro, CA 94578, U.S.A. UPC (50oz): 747599662010 UPC (10lbs): 747599662034 UPC (30lbs): 747599419027
Potential contamination with Salmonella.
FDA FoodVG7274D1 Natural Cream of Mushroom Type Flavor, Net Weight: 50 lbs. bag. Item #: R5302. For Further Processing. Fontana Flavors, Janesville, WI.
VG7274D1 Natural Cream of Mushroom Type Flavor, Net Weight: 50 lbs. bag. Item #: R5302. For Further Processing. Fontana Flavors, Janesville, WI.
Product was made with milk powder recalled by the supplier due to Salmonella contamination.
FDA DevicesAzurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 (722067), Azurion 7 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079, 722224).
Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 (722067), Azurion 7 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079, 722224).
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.
FDA DrugsErythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; (NDC 70710-1048-3).
Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; (NDC 70710-1048-3).
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
FDA FoodLiposomal Mens Liquid Multivitamin Drops. Dosage: 3mL Liquid. Packaging: Aluminum bottle. 90 ml. Firm Address: Vitaminally LLC Chandler, AZ 85225.
Liposomal Mens Liquid Multivitamin Drops. Dosage: 3mL Liquid. Packaging: Aluminum bottle. 90 ml. Firm Address: Vitaminally LLC Chandler, AZ 85225.
Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns.
FDA DevicesMedtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular catheter
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular catheter
Certain lots of product have the potential for a sterile barrier breach.
FDA FoodSolina 6036087 Cr¿me Fraiche Spice Seasoning, 25lb bag
Solina 6036087 Cr¿me Fraiche Spice Seasoning, 25lb bag
potential to be contaminated with Salmonella
FDA FoodMA Cohen's Kippered Herring vacuum packed, weight provided at retail, UPC 7232577992
MA Cohen's Kippered Herring vacuum packed, weight provided at retail, UPC 7232577992
Clostridium botulinum is an uncontrolled hazard
FDA FoodGHIRARDELLI PERFECTLY PREMIUM FRAPPE MIX CHOCOLATE FLAVORED NET WT 10lbs (4.54kg) Ingredients: *** nonfat dry milk *** GHIRARDELLI PERFECTLY PREMIUM FRAPPE MIX CHOCOLATE FLAVORED NET WT 30LB (13.61kg) Ingredients: *** nonfat dry milk *** Distributed by Ghirardelli Chocolate Company, San Leandro, CA 94578 UPC (10lbs): 747599662027 UPC (30lbs): 747599418983
GHIRARDELLI PERFECTLY PREMIUM FRAPPE MIX CHOCOLATE FLAVORED NET WT 10lbs (4.54kg) Ingredients: *** nonfat dry milk *** GHIRARDELLI PERFECTLY PREMIUM FRAPPE MIX CHOCOLATE FLAVORED NET WT 30LB (13.61kg) Ingredients: *** nonfat dry milk *** Distributed by Ghirardelli Chocolate Company, San Leandro, CA 94578 UPC (10lbs): 747599662027 UPC (30lbs): 747599418983
Potential contamination with Salmonella.
FDA FoodNon Fat Dry Milk 1#, Part #: 02000014P. Net Wt 1 lb (453g) PS Seasoning & Spices 216 W Pleasant St Iron Ridge, WI 53035.
Non Fat Dry Milk 1#, Part #: 02000014P. Net Wt 1 lb (453g) PS Seasoning & Spices 216 W Pleasant St Iron Ridge, WI 53035.
Product was made with milk powder recalled by the supplier due to Salmonella contamination.
FDA DrugsPrimidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-11
Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-11
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
FDA Food1P Original Smokehouse Unit for 300 lbs. of Meat, Part #: 180002964. Net Wt 15.10 lbs (6.85kg). PS Seasoning & Spices 216W Pleasant St Iron Ridge, WI 53035.
1P Original Smokehouse Unit for 300 lbs. of Meat, Part #: 180002964. Net Wt 15.10 lbs (6.85kg). PS Seasoning & Spices 216W Pleasant St Iron Ridge, WI 53035.
Product was made with milk powder recalled by the supplier due to Salmonella contamination.
FDA FoodSolina 6036786 Instant Country Gravy Seasoning, 40lb bag
Solina 6036786 Instant Country Gravy Seasoning, 40lb bag
potential to be contaminated with Salmonella
FDA FoodSolina 6036443 Cheddar Cheese Powder Seasoning, 50lb bag
Solina 6036443 Cheddar Cheese Powder Seasoning, 50lb bag
potential to be contaminated with Salmonella
FDA FoodFisher Tex Mex Trail Mix 30 oz plastic jar UPC 070690275941, 6 jars per case
Fisher Tex Mex Trail Mix 30 oz plastic jar UPC 070690275941, 6 jars per case
potential presence of Salmonella
FDA DrugsGas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.
Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
FDA FoodGHIRARDELLI PERFECTLY PREMIUM FRAPPE MIX MOCHA NET WT 50oz (3lbs 2oz) 1.42kg Ingredients: *** nonfat dry milk *** Distributed by Ghirardelli Chocolate Company, San Leandro, CA 94578, U.S.A. UPC: 747599662119
GHIRARDELLI PERFECTLY PREMIUM FRAPPE MIX MOCHA NET WT 50oz (3lbs 2oz) 1.42kg Ingredients: *** nonfat dry milk *** Distributed by Ghirardelli Chocolate Company, San Leandro, CA 94578, U.S.A. UPC: 747599662119
Potential contamination with Salmonella.
FDA FoodLiposomal D3-5000IU Spray Dosage: 3 sprays Liquid. Packaging: Aluminum bottle. 30 ml. Firm Address: Vitaminally LLC Chandler, AZ 85225.
Liposomal D3-5000IU Spray Dosage: 3 sprays Liquid. Packaging: Aluminum bottle. 30 ml. Firm Address: Vitaminally LLC Chandler, AZ 85225.
Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns.
FDA FoodGood & Gather Mexican Street Corn Trail Mix 8 oz bag UPC 085239270240, 8 bags per case
Good & Gather Mexican Street Corn Trail Mix 8 oz bag UPC 085239270240, 8 bags per case
potential presence of Salmonella
FDA FoodBlackstone Parmesan Ranch Seasoning, Net Wt 7.3 oz (207g). UPC 7 17604-04106 2. Manufactured for North Atlantic Imports, LLC, Logan, UT 84321.
Blackstone Parmesan Ranch Seasoning, Net Wt 7.3 oz (207g). UPC 7 17604-04106 2. Manufactured for North Atlantic Imports, LLC, Logan, UT 84321.
Product was made with milk powder recalled by the supplier due to Salmonella contamination.
FDA DrugsMG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%), NET WT 6 oz (170 g), Manufactured by: Pharmacal 1 Pharmacal Way, P.O. Box 198, Jackson, WI 53037.
MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%), NET WT 6 oz (170 g), Manufactured by: Pharmacal 1 Pharmacal Way, P.O. Box 198, Jackson, WI 53037.
Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.