Combat Medical Systems, LLC 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. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

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.