Reported Nov 23, 2022 · Ongoing
0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois,…
ICU Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ICU Medical Inc · 600 N Field Dr · Lake Forest, IL · 60045-4835
Is this the product you have?
- 0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
- Lot codes and dates
- Lot
5829936Exp. MAR 31 2024
- Lot
- Amount recalled
- 137,120 bags
Where it was sold
- Nationwide
Why it was recalled
Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.
This product could cause temporary or reversible health problems — stop using it.
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