Device product
Valkyrie LTOWB Collection (P/N 80-820, NSN 6515016862423). Blood collection convenience kit. The Valkyrie LTOWB Collection Set includes the items needed to allow for pre-screening to identify Low Titer Type O Donors as well as collect the blood from the donor.
Z-1110-2021
Product summary
- Event
- Event 87084
- Status
- Terminated
- Classification
- Class I
- Quantity
- 531 units
- Official record key
device-enforcement:Z-1110-2021
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: MFG3204, MFG3327, MFG3350, MFG3455, MFG3541, MFG3573, MFG3582, MFG3648, MFG3659, MFG3671
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.