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.
FDA Recall Z-1114-2021 · Posted 2021-02-19
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Recalling FirmCombat Medical Systems, LLC
Recall StatusTerminated
Product CodePOQ
Date Initiated2020-12-23
Date Terminated2024-07-09
Product Quantity954 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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