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Terminated

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.

FDA Recall Z-1113-2021 · Posted 2021-02-19

Recall StatusTerminated
Product CodePOQ
Date Initiated2020-12-23
Date Terminated2024-07-09
Product Quantity27090 units

Reason for Recall

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

Firm 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: [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].

Root Cause

Process control

Distribution Pattern

US Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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