Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Consumers and healthcare providers should stop using this product immediately. Contact B BRAUN MEDICAL INC or your healthcare provider for guidance. Notification method: Letter
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DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7387-50.. Generic: DEXTROSE; Brand: DEXTROSE. Reason: Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.. Classification: Class II. Quantity: 17,124 bags. Distribution: US Nationwide.
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Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Fresenius Kabi USA, LLC recalls 5% Dextrose Injection, USP IV solution in freeflex bags due to lack of assurance of sterility. The recall affects batches 6402399, 6402400, and 6402401 with Exp 02/28/2027. Distributors nationwide, including Alaska and Puerto Rico, are notified. Stop using and contact the company for guidance and potential replacement.
Fresenius Kabi USA, LLC recalled 5% Dextrose Injection, USP, 50 mL in a 100 mL freeflex bag, distributed nationwide including Alaska and Puerto Rico. The recall cites lack of assurance of sterility. Consumers and healthcare providers should stop using this product immediately and contact Fresenius Kabi for guidance.
Fresenius Kabi USA, LLC recalls 5% Dextrose Injection, USP 12.5 g per 250 mL in FreeFlex bags due to lack of sterility assurance. The recall covers units distributed nationwide including Alaska and Puerto Rico. Healthcare providers and patients should stop use and consult a healthcare professional.
B. Braun Medical Inc. recalled 16,228 3000 mL saline irrigation bags nationwide in the United States. The recall cites lack of assurance of sterility due to port misalignment, creating a potential for fluid leakage. Healthcare providers and patients should stop using the product immediately and contact the company for guidance.
B. Braun Medical Inc. recalls 47,148 containers of 0.9% Sodium Chloride Injection USP nationwide after detecting particulate matter. The Class I recall affects bottles with NDC 0264-7800-09. Stop using and contact providers for guidance.