Device 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.
Z-2622-2014
Product summary
- Event
- Event 69088
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1150 units
- Official record key
device-enforcement:Z-2622-2014
Official wording
Reason: ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended.
Code information: Lot # 34-128-HE, 34-540-Y1, 35-151-SJ, 35-805-JW, 36-137-SL, 36-469-SL
Distribution pattern: Worldwide Distribution - US (nationwide) in the state of WA, OR and the country of South Africa.
Derived failure modes
-
Unknown
ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended.