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ICU Medical, Inc. recalls STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 60 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer
Recalled October 1, 2014 · FDA recall Z-2620-2014 · ICU Medical
Hazard
ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended. · FDA Class I
Units
1250 units
Sold at
Worldwide Distribution - US (nationwide) in the state of WA, OR and the country of South Africa.
Description
ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended.
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.
Manufacturer(s)
ICU Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →