Drug recall D-0313-2021

Class II Terminated reported Mar 31, 2021

Product

0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045 USA. NDC 0990-7138-09

Reason for recall

Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use

Lots and codes

Lots: 16-808-4B, 16-803-4B, 16-809-4B, Exp. April 01, 2023

Recall details

Recalling firm
ICU Medical Inc, Lake Forest, IL
Quantity
425,628 bottles
Distribution
Distributed Nationwide in the USA to include Puerto Rico
Type
Voluntary: Firm initiated
Recall initiated
March 9, 2021
Terminated
September 28, 2022

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