FDA recall Z-1110-2021

Combat Medical Systems, LLC · Class I · device

Product

Valkyrie LTOWB Collection (P/N 80-820, NSN 6515016862423). Blood collection convenience kit. The Valkyrie LTOWB Collection Set includes the items needed to allow for pre-screening to identify Low Titer Type O Donors as well as collect the blood from the donor.

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-1110-2021