Z-0511-2021 Class II Terminated
FDA device recall Z-0511-2021 was initiated by ICU Medical, Inc. on July 1, 2020 and is designated Class II. Reason for recall: Incorrect filter assemblies in IV administration set. The recall status is terminated (terminated December 1, 2022). Affected quantity: 1100 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 9, 2020
- Initiation Date
- July 1, 2020
- Termination Date
- December 1, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1100 units
Product Description
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.
Distribution Pattern
U.S. Nationwide distribution including in the states of WI, MA, CA, FL, MN, IL, NY.
Code Information
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