PlainRecalls
FDA Devices Critical Class I Terminated

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.

Reported: February 24, 2021 Initiated: December 23, 2020 #Z-1113-2021

Product Description

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.

Reason for Recall

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

Details

Units Affected
27090 units
Distribution
US Nationwide Distribution
Location
Harrisburg, NC

Frequently Asked Questions

What product was recalled?
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.. Recalled by Combat Medical Systems, LLC. Units affected: 27090 units.
Why was this product recalled?
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 24, 2021. Severity: Critical. Recall number: Z-1113-2021.