ICU Medical, Inc.: 60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave¿ Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 - Product Usage: The intravascular administration set is a singl

Is my product affected?

60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave¿ Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 - 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 pati

• UPC 10887709079974

Check against the official notice below — it lists the full affected range.

What happened

ICU Medical, Inc. is recalling approximately 7,500 units of its 60-inch Smallbore Extension Set with MicroClave Clear (Model MC330174, Lot Number 4799374). The product is an intravascular administration set used for intravenous administration. The recall was initiated due to incorrect filter assembly in the affected units.

The product was distributed worldwide and throughout the United States, including in Arizona, California, Colorado, Connecticut, Florida, Idaho, Illinois, Louisiana, Massachusetts, Minnesota, North Carolina, New Jersey, New York, Tennessee, Texas, Virginia, Washington, West Virginia, and Belgium. The source document does not specify what actions affected consumers should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Due to the incorrect filter assembly.

Details from the source

Reason for recall: Due to the incorrect filter assembly. Distribution: Worldwide distribution - U.S. Nationwide distribution including in the states of AZ, CA, CO, CT, FL, ID, IL, LA, MA, MN, NC, NJ, NY, TN, TX, VA, WA and WV. The country of Belgium. Quantity: Total Kits = 7,500 for all four lots Lot/code info: Model List Number: MC330174 UDI: (01)10887709079974(17)250401(30)50(10)4799374 Lot Number: 4799374

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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