The Recall Desk
CriticalFDA (Devices)·Z-1114-2021·Announced 2021-02-24

Combat Medical Systems Recalls Fresh Whole Blood Donor Sets

Combat Medical Systems is recalling 954 Fresh Whole Blood Donor Sets due to a potential bent or disconnected needle in the kit components.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source text explicitly states the agency classification is Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

Combat Medical Systems, LLC is recalling 954 units of the Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306). This blood convenience kit is designed to test for ABO/Rh compatibility and collect whole blood from donors. The affected units were distributed nationwide in the United States.

The recall was initiated because there is a potential for a bent or disconnected needle in one of the components of the convenience kits. The specific lot numbers affected are MFG2977, MFG2991, MFG3073, MFG3118, MFG3279, MFG3328, MFG3332, MFG3337, MFG3339, MFG3499, MFG3507, MFG3512, MFG3533, MFG3704, MFG3751, MFG3761, MFG3760, and MFG3857.

The U.S. Food and Drug Administration has classified this as a Class I recall. Consumers and medical facilities should stop using these kits and contact the manufacturer for further instructions.

The recalled product

Product
Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) . Blood convenience kit. The Fresh Whole Blood Doner Set contains everything needed to test for ABO/Rh compatibility and collect the whole blood from donor.
Manufacturer
Combat Medical Systems, LLC
Category
Medical Device — Blood Collection
Hazard
Affected units
954

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 (18)

  • Lot Numbers: MFG2977
  • MFG2991
  • MFG3073
  • MFG3118
  • MFG3279
  • MFG3328
  • MFG3332
  • MFG3337
  • MFG3339
  • MFG3499
  • MFG3507
  • MFG3512
  • MFG3533
  • MFG3704
  • MFG3751
  • MFG3761
  • MFG3760
  • MFG3857

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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