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

FDA recall notice · announced March 31, 2021 · Icu Medical

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Notes

Distribution: Distributed Nationwide in the USA to include Puerto Rico
Lot/code information: Lots: 16-808-4B, 16-803-4B, 16-809-4B, Exp. April 01, 2023
Quantity: 425,628 bottles
Status: Terminated
Products in this recall event:
- 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 (D-0313-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.