Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) . Blood convenience kit. The Fr...
FDA Recall #Z-1114-2021 — Class I — December 23, 2020
Product Description
Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) . Blood convenience kit. The Fresh Whole Blood Doner Set contains everything needed to test for ABO/Rh compatibility and collect the whole blood from 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
954 units
Distribution
US Nationwide Distribution
Code Information
Lot Numbers: MFG2977, MFG2991, MFG3073, MFG3118, MFG3279, MFG3328, MFG3332, MFG3337, MFG3339, MFG3499, MFG3507, MFG3512, MFG3533, MFG3704, MFG3751, MFG3761, MFG3760, MFG3857
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated