Valkyrie LTOWB Administration (P/N 80-821 NSN 6515016862401). Blood convenience kit. The Val...
FDA Recall #Z-1111-2021 — Class I — December 23, 2020
Product Description
Valkyrie LTOWB Administration (P/N 80-821 NSN 6515016862401). Blood convenience kit. The Valkyrie LTOWB Administration Set contains the items needed to administer the blood to the patient.
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
953 units
Distribution
US Nationwide Distribution
Code Information
Lot Numbers: MFG3205, MFG3353, MFG3403, MFG3440, MFG3540, MFG3574, MFG3584, MFG3649, MFG3660, MFG3698
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated