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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 Drug
Medications & Supplements/Prescription Drugs

0.9% Sodium Chloride Injection Bags Recalled for Sterility Risk

Agency Publication Date: November 16, 2022
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Summary

ICU Medical Inc. has recalled 137,120 bags of 0.9% Sodium Chloride Injection, USP (saline), 100 mL flexible container bags. The recall was initiated because the containers have the potential to leak, which can compromise the sterility of the medication. If you are a healthcare provider using this product, contact the manufacturer or your distributor immediately.

Risk

Leaks in the flexible containers can allow contaminants to enter the saline solution, compromising its sterility. This poses a risk of infection to patients who receive the medication via injection.

What You Should Do

  1. This recall affects 100 mL flexible container bags of 0.9% Sodium Chloride Injection, USP (saline), sold under the ICU Medical, Inc. brand.
  2. Check the product label for NDC 0990-7984-37 and lot number 5829936 with an expiration date of March 31, 2024.
  3. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

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

Affected Products

Product: 0.9% Sodium Chloride Injection, USP (100 mL)
Variants: 100 mL flexible container bag, Rx Only
Lot Numbers:
5829936 (Exp. MAR 31 2024)
NDC:
0990-7984-37

Recall #: D-0062-2023

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91113
Status: Active
Manufacturer: ICU Medical Inc
Sold By: Hospitals; Infusion Centers; Medical Wholesalers
Manufactured In: United States
Units Affected: 137,120 bags
Distributed To: Nationwide

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

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.