Drug 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
D-0313-2021
Product summary
- Firm
- ICU Medical Inc
- Event
- Event 87484
- Status
- Terminated
- Classification
- Class II
- Quantity
- 425,628 bottles
- Official record key
drug-enforcement:D-0313-2021
Official wording
Reason: Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use
Code information: Lots: 16-808-4B, 16-803-4B, 16-809-4B, Exp. April 01, 2023
Distribution pattern: Distributed Nationwide in the USA to include Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
particulate matter