0 — Class II drug recall D-0313-2021
Terminated recall by ICU Medical Inc, reported 2021-03-31, distributed nationwide. Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottl
| Recall number | D-0313-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical Inc, Lake Forest, IL, United States |
| Recall initiated | 2021-03-09 |
| Classified | 2021-03-25 |
| Reported by FDA | 2021-03-31 |
| Terminated | 2022-09-28 |
| Distributed | Nationwide (US) |
| Quantity | 425,628 bottles |
| Reason classes | specification failure |
| NDC | 00990-6138, 00990-6138-03, 00990-6138-22, 00990-7138, 00990-7138-09, 00990-7138-36, 00990-7972, 00990-7972-05, 00990-7972-07 |
| Lot numbers | 16-803-4B, 16-808-4B, 16-809-4B |
| Expiration dates | 2023-04-01 |
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 for recall
Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0313-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.