FDAFDA · Food and drugs·Recall number Z-2622-2014
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.
Published October 1, 2014 · Recall initiated: August 19, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ICU Medical, Inc.
- Distributor
- Worldwide Distribution - US (nationwide) in the state of WA, OR and the country of South Africa.
- Lot
- Lot # 34-128-HE, 34-540-Y1, 35-151-SJ, 35-805-JW, 36-137-SL, 36-469-SL
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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