Drug recall D-0062-2023

Class II Ongoing reported Nov 23, 2022

Product

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

Reason for recall

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

Lots and codes

Lot: 5829936, Exp. MAR 31 2024

Recall details

Recalling firm
ICU Medical Inc, Lake Forest, IL
Quantity
137,120 bags
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
November 9, 2022

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