The Recall Desk
HighFDA (Devices)·Z-1110-2021·Announced 2021-02-24

Combat Medical Systems Recalls Valkyrie LTOWB Blood Collection Kits

Combat Medical Systems is recalling 531 Valkyrie LTOWB blood collection kits due to a potential for bent or disconnected needles.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a potential for a bent or disconnected needle, which poses a risk of harm (injury) even though no specific injuries have been reported in the source text.

Plain-English summary

Combat Medical Systems, LLC is recalling 531 units of the Valkyrie LTOWB Collection (P/N 80-820, NSN 651501686242). This product is a blood collection convenience kit designed to allow for pre-screening to identify Low Titer Type O Donors and to collect blood from the donor.

The recall was initiated because there is the potential for a bent or disconnected needle in one of the components of the convenience kits. The affected lot numbers are MFG3204, MFG3327, MFG3350, MFG3455, MFG3541, MFG3573, MFG3582, MFG3648, MFG3659, and MFG3671.

The product was distributed nationwide in the United States. Users should stop using the affected kits and contact Combat Medical Systems for further instructions.

The recalled product

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.
Manufacturer
Combat Medical Systems, LLC
Category
Medical Device — Blood Collection Kit
Hazard
Affected units
531

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (10)

  • Lot Numbers: MFG3204
  • MFG3327
  • MFG3350
  • MFG3455
  • MFG3541
  • MFG3573
  • MFG3582
  • MFG3648
  • MFG3659
  • MFG3671

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by Combat Medical Systems, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Related recalls

Same manufacturer · Combat Medical Systems, LLC

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Same hazard · needle injury

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