Fresh Whole Blood Transfusion Set (P/N 80-801 NSN 6515016574750) . Blood convenience kit. The Fresh Whole Blood Transfus

FDA device recall Z-1113-2021 · posted 2021-02-19 · Terminated

Recall details

Recalling firm

Combat Medical Systems, LLC

Reason for recall

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

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

POQ

Quantity affected

27090 units

Distribution

US Nationwide Distribution

Date initiated

2020-12-23

Date posted

2021-02-19

Date terminated

2024-07-09

Location

Harrisburg, NC