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.
Recall
- Recall Number
- Z-1113-2021
- Event Number
- 87084
- Firm
- Combat Medical Systems, LLC
- FEI Number
- 3008258694
- Product Code
- POQ
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- December 23, 2020
- Posted
- February 19, 2021
- Terminated
- July 9, 2024
- Address
- 5555 Harrisburg Ind Pk Dr, Harrisburg, NC, 28075-7407
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.
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
The firm, Combat Medical, sent an "URGENT: MEDICAL DEVICE RECALL (# 20-PR-002)" letter dated 12/22/2020 initiating the recall to its customers by email on 12/23/2020. The letter described the product, problem and actions to be taken. The customer was instructed to do the following: Remove the Convenience Kits from all points of use and return to Combat Medical for replacement. Please also complete the attached Recall Acknowledgement and Receipt Form and return it by email: [email protected] or by mail to: Combat Medical , Attn: Recall Coordinator, 5555 Harrisburg Parkway, Harrisburg, NC 28075. Do not use any Convenience Kit found to have a bent or disconnected needle. Upon return of the product, Combat Medical will issue a replacement or credit for each returned kit. Questions directly associated with this recall should be directed to the Director Global Regulatory Affairs (Recall Coordinator), telephone: 855-428-6074 or by email: [email protected].
US Nationwide Distribution
27090 units