ICU Medical, Inc.: ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended.

Agency Publication Date: September 19, 2014

Affected Products

Product: STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9801. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.

Lot # 2768416

Lot Numbers:

2768416

Product: STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 60 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9802. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.

Lot # 2768417

Lot Numbers:

2768417

Product: 83" (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Controller, Clave, Rotating Luer, Item No. B9897. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.

Lot # 2801951

Lot Numbers:

2801951

Product: 98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow Controller, Rotating Luer, Item No. Z2648. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.

Lot # 34-128-HE, 34-540-Y1, 35-151-SJ, 35-805-JW, 36-137-SL, 36-469-SL

Lot Numbers:

34-128-HE

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 69088

Status: Resolved

Manufacturer: ICU Medical, Inc.

Manufactured In: United States

Units Affected: 4 products (3750 units; 1250 units; 100 units; 1150 units)

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Sources: FDA iRES · Raw API Response

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Affected Products

Lot # 2768416

Lot Numbers:

2768416

Lot # 2768417

Lot Numbers:

2768417

Lot # 2801951

Lot Numbers:

2801951

Lot # 34-128-HE, 34-540-Y1, 35-151-SJ, 35-805-JW, 36-137-SL, 36-469-SL

Lot Numbers:

34-128-HE