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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0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-60.. Generic: SODIUM CHLORIDE FOR IRRIGATION; Brand: SODIUM CHLORIDE FOR IRRIGATION. Reason: Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.. Classification: Class II. Quantity: 124,244 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.
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.
B. Braun Medical Inc. recalls 23,100 0.9% Sodium Chloride Injection L 8000 containers nationwide. The recall cites lack of assurance of sterility and potential fluid leakage at a weld site. Stop using immediately and consult a healthcare provider.
B. Braun Medical Inc. recalls 74,088 Lactated Ringers Injection USP containers nationwide over sterility concerns. The recall cites potential fluid leakage at weld sites and lack of assurance of sterility. Healthcare providers and patients should stop use and seek guidance from their supplier or provider immediately.