Combat Medical Systems, LLC: Medical Device Recall in 2021 - (Recall #: Z-1114-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

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.

Product Classification:

Class I

Date Initiated: December 23, 2020

Date Posted: February 24, 2021

Recall Number: Z-1114-2021

Event ID: 87084

Reason for Recall:

There is the potential of a bent or disconnected needle in one of the components of the convenience kits.

Status: Terminated

Product Quantity: 954 units

Code Information:

Lot Numbers: MFG2977, MFG2991, MFG3073, MFG3118, MFG3279, MFG3328, MFG3332, MFG3337, MFG3339, MFG3499, MFG3507, MFG3512, MFG3533, MFG3704, MFG3751, MFG3761, MFG3760, MFG3857

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated