Device 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.
Z-2620-2014
Product summary
- Event
- Event 69088
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1250 units
- Official record key
device-enforcement:Z-2620-2014
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 # 2768417
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.