Valkyrie LTOWB Collection (P/N 80-820, NSN 6515016862423). Blood collection convenience kit. ...
FDA Recall #Z-1110-2021 — Class I — December 23, 2020
Product Description
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.
Recalling Firm
Combat Medical Systems, LLC — Harrisburg, NC
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
531 units
Distribution
US Nationwide Distribution
Code Information
Lot Numbers: MFG3204, MFG3327, MFG3350, MFG3455, MFG3541, MFG3573, MFG3582, MFG3648, MFG3659, MFG3671
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated