Recall: D-0313-2021

Class II - Potentially Harmful

Class IIClassification

2021-03-09Initiated

TerminatedStatus

ICU Medical IncFirm

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

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

Distribution

Distributed Nationwide in the USA to include Puerto Rico

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.