Reported Mar 31, 2021 · Terminated
0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufactured for ICU Medical, Inc., Lake…
ICU Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ICU Medical Inc · 600 N Field Dr · Lake Forest, IL · 60045-4835
Is this the product you have?
- 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
- Lot codes and dates
- Lots
16-808-4B16-803-4B16-809-4BExp. April 012023
- Lots
- Amount recalled
- 425,628 bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use
This product could cause temporary or reversible health problems — stop using it.
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