Fresenius Kabi USA recalled saline injections distributed nationwide, including Alaska and Puerto Rico. The action covers multiple batch numbers with sterility concerns. Healthcare providers and patients should stop using the product immediately and follow official guidance for replacement options.
Lack of Assurance of Sterility
Consumers and healthcare providers should stop using this product immediately. Contact Fresenius Kabi USA, LLC or your healthcare provider for guidance. Notification method: Letter
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Intravenous saline solutions are used to hydrate patients and deliver medications. This recall involves 0.9% Sodium Chloride Injection in single-dose FreeFlex bags distributed nationwide.
Lack of sterility assurance means potential contamination. If contaminated, IV administration can lead to serious infections.
This recall is not part of a broader safety pattern described in the data.
Hospitals and clinics may need to quarantine affected batches and switch to alternatives, potentially delaying treatments and increasing costs.
Recall page: FDA enforcement and manufacturer notification letters
Refunds or replacements will be coordinated by healthcare providers or pharmacy networks; timelines vary by batch
Keep recall letters, batch numbers, expiration dates, and communications with supplier; log any adverse events with the facility risk manager
Brand: Fresenius Kabi USA, LLC. Product: 0.9% Sodium Chloride Injection, USP. Packaging: 1,000 mL FreeFlex bag, single dose, 1,000 mL x 10. NDC: 65219-282-01 (Unit of Use); 65219-282-10 (Unit of Sale). Manufactured by: Fresenius Kabi. Distributed by: Fresenius Medical Care RTG, LLC. Batch numbers and expirations listed in recall notes include: 23SU10001 (Exp 12/31/2026); 24AU10003, 24AU10004, 24AU10005, 24AU10008 (Exp 01/31/2027); 24EU10001, 24EU10002 (Exp 05/31/2027); 24PU10002 (Exp 11/30/2027); 25BU10003, 25EU10005 (Exp 02/29/2028 and 05/31/2028 respectively). Distribution: US Nationwide, AK
No injuries or incidents have been reported in the recall notice.
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Fresenius Kabi USA recalled 0.9% Sodium Chloride Injection nationwide, including Alaska and Puerto Rico. The recall is due to lack of assurance of sterility. Healthcare providers should stop using the product immediately and contact Fresenius Kabi for guidance.
Fresenius Kabi USA recalls 0.9% Sodium Chloride Injection units distributed nationwide, including Alaska and Puerto Rico. The recall cites lack of assurance of sterility. Healthcare providers should stop use and contact Fresenius Kabi for guidance.
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