Drug recall
REF MC330209 6' (15 cm) Appx 0.09 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 0.2 Micron Filter, 1.2…
FDA recall event 86075 · Class II · ICU Medical, Inc.
Key facts
| Event ID | 86075 |
|---|---|
| Recall numbers | Z-0511-2021 |
| Recalling firm | ICU Medical, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Incorrect filter assemblies in IV administration set. |
| Initiation date | Jul 1, 2020 |
| Report date | Dec 9, 2020 |
| Termination date | Dec 1, 2022 |
| City | San Clemente |
| State | CA |
| Country | United States |
| FEI number | 2025816 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: