FDA Device recall Z-0511-2021
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,…
- FDA Device
- Class II
- terminated
- Published 2020-12-09
On 2020-12-09 the FDA classified a Class II recall of 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,… by Icu Medical, citing incorrect filter assemblies in IV administration set.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0511-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-07-01 |
| Published | 2020-12-09 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Icu Medical |
| Distribution | US |
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
Incorrect filter assemblies in IV administration set.
Identifiers
| code_info | Product code : MC330209; Lot numbers:4447222, 4536285, 4572773, 4603405 Unique Device Identifier (UDI)s: (01)108877090…Product code : MC330209; Lot numbers:4447222, 4536285, 4572773, 4603405 Unique Device Identifier (UDI)s: (01)10887709080543(17)241101(30)50(10)4447222; (01)10887709080543(17)241201(30)50(10)4536285; (01)10887709080543(17)250101(30)50(10)4572773; (01)10887709080543(17)250101(30)50(10)4603405 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0511-2021%22
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