US Drug Recall Register
Class II · Moderate risk Terminated Initiated Mar 9, 2021 (5 years ago)

0.9% SODIUM CHLORIDE Irrigation

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

What was recalled

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

Recalling firm
ICU Medical Inc
NDC code
0990-7138-09
Origin
IL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0313-2021

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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