Otsuka ICU Medical recalls 100mL 0.9% Sodium Chloride Injection due to potential flexible container leaks. Affected units have specific lot numbers and expiration dates. Consumers should contact the manufacturer for details.
Lack of Assurance of Sterility: Potential for flexible container leaks.
Otsuka ICU Medical is recalling 100mL 0.9% Sodium Chloride Injection because flexible containers may leak, risking contamination. This could lead to infections if the fluid is used improperly.
The flexible container may leak, which could lead to contamination of the fluid. If the fluid becomes contaminated, it might cause infections when administered to patients.
Healthcare professionals and patients who use this IV fluid for medical treatment. Those with the specific lot number and expiration date are most at risk.
Check for the lot number 1029921 and expiration date of 28 February 2027 on the product label. This product is sold under the brand name ICU Medical.
Look for the lot number 1029921 and expiration date of 28 February 2027 on the product label.
The recall states there is a potential for container leaks, which could lead to contamination. The manufacturer has not provided a remedy, so it is recommended to check the product details and contact them for further instructions.
The recall does not specify a remedy, so you should check the product details and contact Otsuka ICU Medical for further instructions.
Check for the lot number 1029921 and expiration date of 28 February 2027 on the product label.
We’ve drafted a message you can send Otsuka ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall D-0143-2026 — Otsuka ICU Medical Otsuka ICU Medical Hello, I own a Otsuka ICU Medical that is covered by recall D-0143-2026 from Otsuka 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.
