REF MC330209 6' — Class II medical device recall Z-0511-2021
Terminated recall by ICU Medical, Inc., reported 2020-12-09, distributed nationwide. Incorrect filter assemblies in IV administration set.
| Recall number | Z-0511-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical, Inc., San Clemente, CA, United States |
| Recall initiated | 2020-07-01 |
| Classified | 2020-12-01 |
| Reported by FDA | 2020-12-09 |
| Terminated | 2022-12-01 |
| Distributed | Nationwide (US) |
| Quantity | 1,100 units |
| UPC / GTIN / UDI-DI | 10887709080543 |
| Lot numbers | 4447222, 4536285, 4572773, 4603405 |
| Model numbers | MC330209 |
Product
REF MC330209 6' (15 cm) Appx 0.09 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 0.2 Micron Filter, 1.2 Micron Filter, 3 Clamps (Blue, Yellow, White), Rotating Luer - Product Usage: The intravascular administration set is a single use, sterile, non-pyrogenic device, which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle catheter (which is inserted into a vein). Directions for Use: icumedical IV Extension Sets Clave/MicroClave/NanoClave Connectors Antimicrobial Clave/MicroClave Connectors Spiros Closed Male Luer.
Reason for recall
Incorrect filter assemblies in IV administration set.
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/Z-0511-2021. 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.