FDAFDA · Food and drugs·Recall number D-0313-2021
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
Published March 31, 2021 · Recall initiated: March 9, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- SODIUM CHLORIDE
- Manufacturer
- ICU Medical Inc
- Distributor
- Distributed Nationwide in the USA to include Puerto Rico
- Lot
- Lots: 16-808-4B, 16-803-4B, 16-809-4B, Exp. April 01, 2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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