Device product
Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) . Blood convenience kit. The Fresh Whole Blood Doner Set contains everything needed to test for ABO/Rh compatibility and collect the whole blood from donor.
Z-1114-2021
Product summary
- Event
- Event 87084
- Status
- Terminated
- Classification
- Class I
- Quantity
- 954 units
- Official record key
device-enforcement:Z-1114-2021
Official wording
Reason: There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
Code information: Lot Numbers: MFG2977, MFG2991, MFG3073, MFG3118, MFG3279, MFG3328, MFG3332, MFG3337, MFG3339, MFG3499, MFG3507, MFG3512, MFG3533, MFG3704, MFG3751, MFG3761, MFG3760, MFG3857
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.