Class 1 Device Recall Fresh Whole Blood Donor Set

• Date Initiated by Firm: December 23, 2020
• Date Posted: February 19, 2021
• Recall Status: Terminated on July 09, 2024
• Recall Number: Z-1114-2021
• Recall Event ID: 87084
• Product Classification: Blood transfusion kit - Product Code POQ
• Product: 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.
• Code Information: Lot Numbers: MFG2977, MFG2991, MFG3073, MFG3118, MFG3279, MFG3328, MFG3332, MFG3337, MFG3339, MFG3499, MFG3507, MFG3512, MFG3533, MFG3704, MFG3751, MFG3761, MFG3760, MFG3857
• Recalling Firm/ Manufacturer: Combat Medical Systems, LLC; 5555 Harrisburg Ind Pk Dr; Harrisburg NC 28075-7407
• For Additional Information Contact: Kimberly Reed; 855-428-6074
• Manufacturer Reason for Recall: There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
• FDA Determined Cause: Process control
• Action: 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: recalls@combatmedical.com 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: recalls@combatmedical.com.
• Quantity in Commerce: 954 units
• Distribution: US Nationwide Distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.