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Recall Observatory FDA recall evidence

Device product

Valkyrie LTOWB Administration (P/N 80-821 NSN 6515016862401). Blood convenience kit. The Valkyrie LTOWB Administration Set contains the items needed to administer the blood to the patient.

Z-1111-2021

December 23, 2020

Class I

Product summary

Firm
Combat Medical Systems, LLC
Event
Event 87084
Status
Terminated
Classification
Class I
Quantity
953 units
Official record key
device-enforcement:Z-1111-2021

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: MFG3205, MFG3353, MFG3403, MFG3440, MFG3540, MFG3574, MFG3584, MFG3649, MFG3660, MFG3698

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is the potential of a bent or disconnected needle in one of the components of the convenience kits.