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.
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 fluid used for various IV therapies. It is distributed nationally for medical use.
Lack of sterility assurance means the product could be contaminated during manufacturing, potentially causing infections or sepsis if administered.
This recall is not described as part of a broader industry pattern in the provided data.
Healthcare facilities and patients could face infection risks; providers may need to replace IV fluids and adjust treatment plans.
Package labeling and the recall notice from FDA enforcement site
Refund or replacement process will be guided by Fresenius Kabi or the purchasing facility, typically within weeks
Keep recall notification, lot numbers, expiration dates, and supplier communications as records
Product: 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL). Size: 1,000 mL in a single-dose FreeFlex bag. Form: Rx only. Jointly distributed by BD Becton, Dickinson and Company and Fresenius Kabi. NDC: 17271-701-07. Batch: 24EU10010. Expiration: 05/31/2027. Sold/distributed in the US, including Alaska and Puerto Rico.
No specific injuries or incidents are described in the provided data. The recall status is active with high hazard classification.
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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.
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.