Home / Recalls / Combat Medical Systems, LLC / Z-1111-2021

Z-1111-2021 Class I Terminated

Recalled by Combat Medical Systems, LLC — Harrisburg, NC

FDA device recall Z-1111-2021 was initiated by Combat Medical Systems, LLC on December 23, 2020 and is designated Class I. Reason for recall: There is the potential of a bent or disconnected needle in one of the components of the convenience kits. The recall status is terminated (terminated July 9, 2024). Affected quantity: 953 units.

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
953 units

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.

Distribution Pattern

US Nationwide Distribution

Code Information

Lot Numbers: MFG3205, MFG3353, MFG3403, MFG3440, MFG3540, MFG3574, MFG3584, MFG3649, MFG3660, MFG3698

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-1113-2021 Class I — Fresh Whole Blood Transfusion Set (P/N 80-801 NSN 6515016574750) . Blood conven (December 23, 2020)

FDA data resources