Device product
Low Titer Type O FWB Transfusion Set (P/N 80-875 NSN 651501684994). Blood convenience kit. The Transfusion Set includes the items necessary to administer the collected blood to a patient.
Z-1112-2021
Product summary
- Event
- Event 87084
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1021 units
- Official record key
device-enforcement:Z-1112-2021
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: MFG2267, MFG2347, MFG2375, MFG2430, MFG2538, MFG2637, MFG2655, MFG2693, MFG2708, MFG2754, MFG2828, MFG3120, MFG3186, MFG3340, MFG3378, MFG3386, MFG3586, MFG3640
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.