Reported Feb 24, 2021 · Terminated

Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) . Blood convenience kit. The Fresh Whole Blood Doner Set…

Combat Medical Systems, LLC

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Combat Medical Systems, LLC · 5555 Harrisburg Ind Pk Dr · Harrisburg, NC · 28075-7407

Is this the product you have?

  • 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.
Lot codes and dates
  • Lot Numbers
    • MFG2977
    • MFG2991
    • MFG3073
    • MFG3118
    • MFG3279
    • MFG3328
    • MFG3332
    • MFG3337
    • MFG3339
    • MFG3499
    • MFG3507
    • MFG3512
    • MFG3533
    • MFG3704
    • MFG3751
    • MFG3761
    • MFG3760
    • MFG3857
Amount recalled
954 units

This recall covers 5 products

The agency filed one notice per product. You are reading one of them; the other 4 are below.

Where it was sold

  • Nationwide

Why it was recalled

Stop using this product now

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

Using this product could cause serious injury, illness or death — stop using it now.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 9, 2024 · Data as of Sep 19, 5:40 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.