Home / Recalls / Combat Medical Systems, LLC / Z-1113-2021

Z-1113-2021 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
27090 units

Product Description

Fresh Whole Blood Transfusion Set (P/N 80-801 NSN 6515016574750) . Blood convenience kit. The Fresh Whole Blood Transfusion Set contains everything needed to test for ABO/Rh compatibility and perform a fresh whole blood transfusion in a compact sealed package.

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: MFG2980, MFG3051, MFG3059, MFG3069, MFG3070, MFG3096, MFG3101, MFG3107, MFG3127, MFG3138, MFG3164, MFG3174, MFG3193, MFG3203, MFG3217, MFG3228, MFG3234, MFG3239, MFG3258, MFG3264, MFG3277, MFG3302, MFG3112, MFG3331, MFG3373, MFG3354, MFG3382, MFG3387, MFG3394, MFG3399, MFG3427, MFG3431, MFG3463, MFG3482, MFG3498, MFG3519, MFG3521, MFG3555, MFG3583, MFG3572, MFG3622, MFG3653, MFG3676, MFG3734, MFG3742, MFG3755, MFG3758, MFG3762, MFG3801, MFG3802, MFG3839, MFG3861, MFG3870, MFG3876

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-1114-2021 Class I — Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) . Blood convenienc (December 23, 2020)
  • Z-1111-2021 Class I — Valkyrie LTOWB Administration (P/N 80-821 NSN 6515016862401). Blood convenience (December 23, 2020)