Z-1114-2021Class I

Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) . Blood convenience kit. The Fresh Whole Blood...

Name: Z-1114-2021 Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) . Blood convenience kit. The Fresh Whole Blood...
Creator: Combat Medical Systems, LLC
Published: 2020-12-23
License: https://open.fda.gov/license/

Safeguard US Operating LLC / initiated 2020-12-23 / Terminated / root cause: manufacturing process

FDA source

Combat Medical Systems, LLC began a recall of 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... on 2020-12-23. FDA classified it as Class I and gives the reason as "There is the potential of a bent or disconnected needle in one of the components of the convenience kits". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1114-2021
Classification: Class I
Status: Terminated
Initiated: 2020-12-23
Posted: 2021-02-19
Terminated: 2024-07-09
Recalling firm: Safeguard US Operating LLC
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.
Product code: POQ Blood Transfusion Kit
Reason for recall: There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
Root cause tag: manufacturing process
FDA root 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: [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].
Quantity in commerce: 954 units
Distribution: US Nationwide Distribution
Product codes and lots: Lot Numbers: MFG2977, MFG2991, MFG3073, MFG3118, MFG3279, MFG3328, MFG3332, MFG3337, MFG3339, MFG3499, MFG3507, MFG3512, MFG3533, MFG3704, MFG3751, MFG3761, MFG3760, MFG3857

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1114-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1110-2021	Class I	Terminated	Voluntary: Firm initiated	2021-02-24	2021-02-18
Z-1111-2021	Class I	Terminated	Voluntary: Firm initiated	2021-02-24	2021-02-18
Z-1112-2021	Class I	Terminated	Voluntary: Firm initiated	2021-02-24	2021-02-18
Z-1113-2021	Class I	Terminated	Voluntary: Firm initiated	2021-02-24	2021-02-18
Z-1114-2021	Class I	Terminated	Voluntary: Firm initiated	2021-02-24	2021-02-18

Product code POQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)