The Recall Desk
SevereFDA (Devices)·Z-1112-2021·Announced 2021-02-24

Combat Medical Systems Recalls Low Titer Type O FWB Transfusion Sets

Combat Medical Systems, LLC is recalling 1021 units of Low Titer Type O FWB Transfusion Sets due to the potential for bent or disconnected needles in the components.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class I, which per the rubric mandates a minimum severity score of 4. The defect involves a bent or disconnected needle in a device used to administer blood, representing a significant risk of injury.

Plain-English summary

Combat Medical Systems, LLC has issued a recall for its Low Titer Type O FWB Transfusion Sets (P/N 80-875, NSN 651501684994). The product is described as a blood convenience kit that includes the items necessary to administer collected blood to a patient. A total of 1,021 units are being recalled.

The recall was initiated because there is the potential for a bent or disconnected needle in one of the components of the convenience kits. This defect could compromise the safety and functionality of the device during use.

Affected products were distributed nationwide across the United States. The specific lot numbers included in this recall are MFG2267, MFG2347, MFG2375, MFG2430, MFG2538, MFG2637, MFG2655, MFG2693, MFG2708, MFG2754, MFG2828, MFG3120, MFG3186, MFG3340, MFG3378, MFG3386, MFG3586, and MFG3640.

The U.S. Food and Drug Administration has classified this recall as a Class I recall, which is the most serious category of recall used by the FDA.

The recalled product

Product
Low Titer Type O FWB Transfusion Set (P/N 80-875 NSN 651501684994). Blood convenience kit. The Transfusion Set includes the items necessary to administer the collected blood to a patient.
Manufacturer
Combat Medical Systems, LLC
Category
Medical Device — Transfusion Set
Hazard
Affected units
1,021

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: MFG2267
  • MFG2347
  • MFG2375
  • MFG2430
  • MFG2538
  • MFG2637
  • MFG2655
  • MFG2693
  • MFG2708
  • MFG2754
  • MFG2828
  • MFG3120
  • MFG3186
  • MFG3340
  • MFG3378
  • MFG3386
  • MFG3586
  • MFG3640

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

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Same hazard · needle defect

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