D-0313-2021 Class II Terminated
FDA drug recall D-0313-2021 was initiated by ICU Medical Inc on March 9, 2021 and is designated Class II. Reason for recall: Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use The recall status is terminated (terminated September 28, 2022). Affected quantity: 425,628 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 31, 2021
- Initiation Date
- March 9, 2021
- Termination Date
- September 28, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 425,628 bottles
Product Description
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
Distribution Pattern
Distributed Nationwide in the USA to include Puerto Rico
Code Information
Lots: 16-808-4B, 16-803-4B, 16-809-4B, Exp. April 01, 2023