FDA recall Z-1112-2021

Combat Medical Systems, LLC · Class I · device

Product

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.

Reason for recall

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

Distribution

US Nationwide Distribution

Key facts

Status
Terminated
Initiation date
2020-12-23
Report date
2021-02-24
Termination date
2024-07-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Harrisburg, NC, United States

Primary source

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