FDA-Device2021-02-24Class I

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.

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
1021 units
Manufactured in
5555 Harrisburg Ind Pk Dr, N/A, Harrisburg, NC, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1112-2021

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