Fresenius Kabi recalls 0.9% Sodium Chloride Injection (100mL) due to lack of sterility assurance. Affected batches expire by 01/31/2027 and 02/28/2027. No remedy specified in recall notice.
Lack of Assurance of Sterility
Fresenius Kabi is recalling 0.9% Sodium Chloride Injection (100mL) because it may not be sterile. This could lead to infections if used improperly. The recall affects specific batches with expiration dates up to 06/30/2027.
The product may not be sterile, which could cause infections if used in medical procedures. This is a serious concern for injectable medications that require strict sterility standards.
Healthcare professionals and patients using this injectable solution for medical purposes. Those with the specific batch numbers listed are most at risk.
Check for batch numbers 6402299-6402578 on the 100mL freeflex bag. The expiration dates range from 01/31/2027 to 06/30/2027. This product is prescription-only.
Identify the batch number and expiration date on the 100mL freeflex bag.
The recall states there is a lack of sterility assurance, so it may not be safe. Do not use the product until the recall is resolved.
Batches 6402299, 6402300, 6402301, 6402302, 6402303, 6402305, 6402398, 6402467, 6402577, 6402578 with expiration dates up to 06/30/2027.
The recall does not specify a return or remedy, so no action is required beyond checking the product details.
We’ve drafted a message you can send Fresenius Kabi to request your refund or repair — edit it as you like.
Subject: Recall D-0426-2026 — Fresenius Kabi Fresenius Kabi Hello, I own a Fresenius Kabi that is covered by recall D-0426-2026 from Fresenius Kabi. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
