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.
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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0.9% Sodium Chloride Injection is a sterile IV solution used for fluid and electrolyte management in medical settings. It is packaged in 100 mL single-dose freeflex bags.
Lack of assurance of sterility means the solution may be contaminated, posing infection or sepsis risk when administered IV.
This recall is not part of a broader industry pattern in the provided data.
Healthcare facilities must identify affected lots and quarantine them. The recall carries a high safety urgency due to potential infection risk.
NDC and batch numbers on label; recall notice via FDA enforcement page
Refund or replacement details to be provided by manufacturer; expect communications by letter or facility channels
Document lot numbers, expiry dates, and dates of notification; keep correspondence with Fresenius Kabi and facility records
Product: 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a single-dose freeflex bag. Manufacturer: Fresenius Kabi USA, LLC. Distributor: BD Beckton Dickinson and Company. Sold in: United States nationwide, including Alaska and Puerto Rico. NDC: 17271-701-03. Classification: Class II. Recall date: 2026-03-11. Status: ACTIVE. Units affected: Not specified in provided data.
No specific injuries or incidents are mentioned in the provided data.
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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.
BD and Fresenius Kabi recall 1,000 mL sodium chloride injection due to lack of assurance of sterility. The U.S. distribution covers nationwide, Alaska, and Puerto Rico. Health care providers should stop use and seek guidance from Fresenius Kabi or a clinician immediately.
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.
BD Becton, Dickinson and Company and Fresenius Kabi USA recall 0.9% Sodium Chloride Injection, USP, 250 mL in a single-dose bag nationwide, including Alaska and Puerto Rico. The recall cites lack of assurance of sterility. Healthcare providers and patients should stop using the product immediately and follow guidance from Fresenius Kabi or their provider.