Reported Dec 9, 2020 · Terminated
REF MC330209 6' (15 cm) Appx 0.09 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 0.2 Micron Filter, 1.2 Micron…
ICU Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ICU Medical, Inc. · 951 Calle Amanecer · San Clemente, CA · 92673-6212
Is this the product you have?
- 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 UsageThe 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 Useicumedical IV Extension Sets Clave/MicroClave/NanoClave Connectors Antimicrobial Clave/MicroClave Connectors Spiros Closed Male Luer
- Lot codes and dates
5 of 5 products
Products covered by this recall # Barcodes Product as published 1 MC330209 2 10887709080543Lot numbers:4447222, 4536285, 4572773, 4603405 Unique Device Identifier (UDI)s: (01)10887709080543(17)241101(30)50(10)4447222 3 10887709080543(01)10887709080543(17)241201(30)50(10)4536285 4 10887709080543(01)10887709080543(17)250101(30)50(10)4572773 5 10887709080543(01)10887709080543(17)250101(30)50(10)4603405 - Amount recalled
- 1100 units
Where it was sold
Why it was recalled
Incorrect filter assemblies in IV administration set.
This product could cause temporary or reversible health problems — stop using it.
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