FDA-Device2021-02-24Class I
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.
Combat Medical Systems, LLC
Hazard
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
Sold states
US Nationwide Distribution
Affected count
27090 units
Manufactured in
5555 Harrisburg Ind Pk Dr, N/A, Harrisburg, NC, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1113-2021Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief