ICU Medical, Inc.: 154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides acc

Is my product affected?

154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - 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 n

• UPC 1084061905261

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

What happened

ICU Medical, Inc. is recalling approximately 7,500 intravascular administration sets due to incorrect filter assembly. The affected product is a 154 cm extension set with a 1.2 micron filter (Model 011-H3182, Lot Number 4806428). These sterile, single-use devices were distributed worldwide, including throughout numerous U.S. states and Belgium.

The recall affects intravascular administration sets that may have been used in healthcare settings nationwide. The source document does not specify a remedy or corrective action for consumers who may have received 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: Distributed O.U.S. only Model List Number: 011-H3182 UDI: (01)1084061905261(17)250401(30)50(10)4806428 Lot Number: 4806428

Source

Official record: FDA (Device enforcement) ↗

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

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