ICU Medical, Inc.: Due to the incorrect filter assembly.

Agency Publication Date: February 5, 2021

Affected Products

Product: 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 administration set s needle or catheter (which is inserted into a vein).

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

Lot Numbers:

Number

Product: 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 patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

Model List Number: MC330174 UDI: (01)10887709079974(17)250401(30)50(10)4799374 Lot Number: 4799374

Lot Numbers:

Number

Product: 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 set s needle or catheter (which is inserted into a vein).

Model List Number: Z3532 UDI: (01)10887709033174(17)250401(30)50(10)4795091 Lot Number: 4795091

Lot Numbers:

Number

Product: 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 needle or catheter (which is inserted into a vein).

Distributed O.U.S. only Model List Number: 011-H3182 UDI: (01)1084061905261(17)250401(30)50(10)4806428 Lot Number: 4806428

Lot Numbers:

Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86973

Status: Resolved

Manufacturer: ICU Medical, Inc.

Manufactured In: United States

Units Affected: 4 products (Total Kits = 7,500 for all four lots)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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Affected Products

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

Lot Numbers:

Number

Model List Number: MC330174 UDI: (01)10887709079974(17)250401(30)50(10)4799374 Lot Number: 4799374

Lot Numbers:

Number

Model List Number: Z3532 UDI: (01)10887709033174(17)250401(30)50(10)4795091 Lot Number: 4795091

Lot Numbers:

Number

Distributed O.U.S. only Model List Number: 011-H3182 UDI: (01)1084061905261(17)250401(30)50(10)4806428 Lot Number: 4806428

Lot Numbers:

Number