Device product
Nipro Safe Touch TULIP Safety Fistula Needle, FT+152530TP, for use as a blood access device for blood purification and for other treatments requiring an extracorporeal circuit of larger volumes of blood.
Z-0161-2016
Product summary
- Event
- Event 72365
- Status
- Terminated
- Classification
- Class II
- Quantity
- 50,000 pieces
- Official record key
device-enforcement:Z-0161-2016
Official wording
Reason: Some 1 1/4" needles were packaged and labeled in the 1" blister package.
Code information: Lot # 15C03
Distribution pattern: Indiana
Derived failure modes
-
Unknown
Some 1 1/4" needles were packaged and labeled in the 1" blister package.