FDA-Device2021-02-24Class I
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.
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
531 units
Manufactured in
5555 Harrisburg Ind Pk Dr, N/A, Harrisburg, NC, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1110-2021Don't want to check this manually?
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