The Recall Desk
HighFDA (Devices)·Z-1113-2021·Announced 2021-02-24

Combat Medical Systems Recalls Fresh Whole Blood Transfusion Sets

Combat Medical Systems is recalling Fresh Whole Blood Transfusion Sets due to a potential for bent or disconnected needles in the kit components.

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 injury (bent or disconnected needle) where no specific injuries have been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Combat Medical Systems, LLC is recalling 27,090 units of Fresh Whole Blood Transfusion Sets (P/N 80-801 NSN 6515016574750). These blood convenience kits contain components necessary to test for ABO/Rh compatibility and perform fresh whole blood transfusions.

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 affected products were distributed nationwide in the United States.

Consumers should stop using the affected products and contact the manufacturer for further instructions. The recall covers specific lot numbers, including MFG2980, MFG3051, and MFG3059, among others.

The recalled product

Product
Fresh Whole Blood Transfusion Set (P/N 80-801 NSN 6515016574750) . Blood convenience kit. The Fresh Whole Blood Transfusion Set contains everything needed to test for ABO/Rh compatibility and perform a fresh whole blood transfusion in a compact sealed package.
Manufacturer
Combat Medical Systems, LLC
Category
Medical Device — Blood Transfusion Equipment
Hazard
Affected units
27,090

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 (20)

  • Lot numbers: MFG2980
  • MFG3051
  • MFG3059
  • MFG3069
  • MFG3070
  • MFG3096
  • MFG3101
  • MFG3107
  • MFG3127
  • MFG3138
  • MFG3164
  • MFG3174
  • MFG3193
  • MFG3203
  • MFG3217
  • MFG3228
  • MFG3234
  • MFG3239
  • MFG3258
  • MFG3264

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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