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
#BarcodesProduct as published
1MC330209
210887709080543Lot numbers:4447222, 4536285, 4572773, 4603405 Unique Device Identifier (UDI)s: (01)10887709080543(17)241101(30)50(10)4447222
310887709080543(01)10887709080543(17)241201(30)50(10)4536285
410887709080543(01)10887709080543(17)250101(30)50(10)4572773
510887709080543(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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 1, 2022 · Data as of Sep 19, 4:56 PM UTC

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