ICU Medical, Inc.: 60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which pro

Is my product affected?

60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - 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 administratio

• UPC 10887709085439

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 PUR YELLOW SMALLBORE SET with FILTER (Model B2209) due to an incorrect filter assembly in the device. The intravascular administration set is a single-use, sterile medical device that was distributed worldwide, including throughout the United States in multiple states and in Belgium. The affected lot number is 4794177.

The recall record does not specify a remedy or recommended action for consumers who may have this product.

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: B2209 UDI: (01)10887709085439(17)250401(30)50(10)4794177 Lot Number: 4794177

Source

Official record: FDA (Device enforcement) ↗

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

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