ICU Medical, Inc.: 7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which prov

Is my product affected?

7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - 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

• UPC 10887709033174

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 7-inch MicroCLAVE Filter smallbore intravascular administration sets (Model Z3532, Lot Number 4795091) due to incorrect filter assembly. These single-use, sterile devices are used for delivering medication and fluids directly into the bloodstream. The affected products were distributed worldwide, with U.S. distribution across multiple states including Arizona, California, Colorado, Connecticut, Florida, Idaho, Illinois, Louisiana, Massachusetts, Minnesota, North Carolina, New Jersey, New York, Tennessee, Texas, Virginia, Washington, and West Virginia, as well as in Belgium.

According to the recall record, no remedy or recommended action is specified 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: Z3532 UDI: (01)10887709033174(17)250401(30)50(10)4795091 Lot Number: 4795091

Source

Official record: FDA (Device enforcement) ↗

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

Related recalls

• MicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic cocci and listeria monocytogenes.2020-12-02
• 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 administratio2020-12-02
• 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 pati2020-12-02
• 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 n2020-12-02
• Stryker Medela REF 077.0193 AXS Universal Aspiration Tubing (01)07612367053921 - Product Usage: AXS Universal Aspiration Tubing is used with the Dominant Flex Surgical Suction Pump.2020-12-02

All FDA (Device enforcement) recalls