Home / Recalls / Combat Medical Systems, LLC / Z-1114-2021

Z-1114-2021 Class I Terminated

Recalled by Combat Medical Systems, LLC — Harrisburg, NC

Recall Details

Product Type
Devices
Report Date
February 24, 2021
Initiation Date
December 23, 2020
Termination Date
July 9, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
954 units

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.

Distribution Pattern

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

Other recalls by Combat Medical Systems, LLC

  • Z-1110-2021 Class I — Valkyrie LTOWB Collection (P/N 80-820, NSN 6515016862423). Blood collection con (December 23, 2020)
  • Z-1112-2021 Class I — Low Titer Type O FWB Transfusion Set (P/N 80-875 NSN 651501684994). Blood conve (December 23, 2020)
  • Z-1113-2021 Class I — Fresh Whole Blood Transfusion Set (P/N 80-801 NSN 6515016574750) . Blood conven (December 23, 2020)
  • Z-1111-2021 Class I — Valkyrie LTOWB Administration (P/N 80-821 NSN 6515016862401). Blood convenience (December 23, 2020)