ICU Medical recalls 100mL 0.9% Sodium Chloride Injection bags due to potential leakage compromising sterility. Affected lots expire MAR 2024.
Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.
ICU Medical is recalling 100mL 0.9% Sodium Chloride Injection bags that may leak and compromise sterility. This could lead to infections if used in medical settings.
The flexible bags may leak during use, which could contaminate the solution and cause infections. This is a sterility risk in medical settings where the solution is used directly for patient treatment.
Healthcare professionals using these injections for medical treatments. Patients receiving IV fluids through this product are at risk if the bag leaks.
Check for the product name '0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag' with NDC 0990-7984-37. Lot number 5829936, expiring March 31, 2024.
Verify the lot number (5829936) and expiration date (March 31, 2024) on the packaging.
The product may leak and compromise sterility, so it should not be used until the recall is resolved.
Look for the NDC 0990-7984-37 and lot number 5829936 on the packaging, which expires March 31, 2024.
Check the product details and contact ICU Medical if you have the recalled lot number.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall D-0062-2023 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall D-0062-2023 from ICU Medical. 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.
