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 Usage: The intravascular administration set is a single use, sterile, non-pyrogenic device, which provides access for th
Check against the official notice below — it lists the full affected range.
ICU Medical, Inc. is recalling approximately 1,100 units of its Smallbore Trifuse Extension Set (product code MC330209) due to incorrect filter assemblies in the IV administration set. The affected products were distributed nationwide across the United States, including in Wisconsin, Massachusetts, California, Florida, Minnesota, Illinois, and New York. The recall involves four specific lot numbers: 4447222, 4536285, 4572773, and 4603405.
The source document 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.
Incorrect filter assemblies in IV administration set.
Reason for recall: Incorrect filter assemblies in IV administration set. Distribution: U.S. Nationwide distribution including in the states of WI, MA, CA, FL, MN, IL, NY. Quantity: 1100 units Lot/code info: Product code : MC330209; Lot numbers:4447222, 4536285, 4572773, 4603405 Unique Device Identifier (UDI)s: (01)10887709080543(17)241101(30)50(10)4447222; (01)10887709080543(17)241201(30)50(10)4536285; (01)10887709080543(17)250101(30)50(10)4572773; (01)10887709080543(17)250101(30)50(10)4603405
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.