RecallRadar

FDA Device recall Z-1111-2021

Valkyrie LTOWB Administration (P/N 80-821 NSN 6515016862401)

On 2021-02-24 the FDA classified a Class I recall of Valkyrie LTOWB Administration (P/N 80-821 NSN 6515016862401) by Combat Medical Systems, citing there is the potential of a bent or disconnected needle in one of the components of the convenience kits.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1111-2021
ClassificationClass I
Statusterminated
Initiated2020-12-23
Published2021-02-24
Last updated2026-09-13 11:56 UTC
CompanyCombat Medical Systems
DistributionUS

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.

Reason

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

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1111-2021%22

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