Device product
NIPRO SafeTouch II Safety AVF Needle, 17G x 1 ¿ inch. Item code FS+173230BC.
Z-0599-2016
Product summary
- Event
- Event 72707
- Status
- Terminated
- Classification
- Class III
- Quantity
- 160,000 pieces.
- Official record key
device-enforcement:Z-0599-2016
Official wording
Reason: Device has the potential to have torn wings.
Code information: Model No.: FS+173230BC, Lot #14A22 and Lot #14A26.
Distribution pattern: US distribution including TN.
Derived failure modes
-
Unknown
Device has the potential to have torn wings.