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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Vet
Pets & Animals/Pet Medications

ICU Medical 0.9% Sodium Chloride Injection Recalled for Potential Leaks

Agency Publication Date: November 21, 2022
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Summary

ICU Medical Inc. is recalling 1,920 bags of 0.9% Sodium Chloride Injection (USP 100 mL) because the bags may leak, which compromises the sterility of the saline solution. This veterinary product is a prescription-only injectable used in animal healthcare. While no incidents or injuries have been reported to date, the loss of sterility in an injectable product can lead to serious infections in treated animals. The affected bags were distributed to North Carolina and are identified by lot number 5829936.

Risk

Leaking bags can allow bacteria or other contaminants to enter the solution, making it no longer sterile. Administering a non-sterile injectable product to an animal poses a significant risk of infection or other serious health complications.

What You Should Do

  1. Check the product packaging for lot number 5829936 and an expiration date of 31-MAR-2024.
  2. If you have animal health concerns regarding a pet or animal that received this injection, contact your veterinarian immediately.
  3. Stop using the recalled product and contact ICU Medical Inc. or your distributor to arrange for the return of any unused bags.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 if you have further questions or need to report an issue.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return or proper disposal.

Affected Products

Product: 0.9% Sodium Chloride Injection, USP (100 mL)by ICU Medical, Inc.
Variants: Rx Only
UPC Codes:
00309907984377
Lot Numbers:
5829936 (Exp. 31-MAR-2024)
NDC:
0990-7984-37

Recall #: V-0015-2023

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91152
Status: Resolved
Manufacturer: ICU Medical Inc
Sold By: veterinary distributors
Manufactured In: United States
Units Affected: 1920 bags
Distributed To: North Carolina
Agency Last Updated: November 23, 2022

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response