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FDANovember 9, 2022drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.

What to do

FDA enforcement status: Ongoing

Brands named

icu medicalicu

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 — Recall Details · AllClear