FDA Drug recall 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 U…
- FDA Drug
- Class II
- terminated
- Published 2021-03-31
On 2021-03-31 the FDA classified a Class II recall of 0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045 U… by Icu Medical, citing presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0313-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-09 |
| Published | 2021-03-31 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Icu Medical |
| Distribution | US |
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
Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use
Identifiers
| ndc | 0990-7138-09 |
|---|---|
| ndc | 0990-7138-36 |
| ndc | 0990-6138-22 |
| ndc | 0990-6138-03 |
| ndc | 0990-7972-05 |
| ndc | 0990-7972-07 |
| code_info | Lots: 16-808-4B, 16-803-4B, 16-809-4B, Exp. April 01, 2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0313-2021%22
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