CLASS I Device recall · Reported 24 Feb 2021 · FDA Enforcement Report

Fresh Whole Blood Transfusion Set recalled by Combat Medical Systems

Combat Medical Systems is recalling Fresh Whole Blood Transfusion Set (, distributed nationwide in the US. The recall was initiated on 23 Dec 2020 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLot numbers: MFG2980, MFG3051, MFG3059, MFG3069, MFG3070, MFG3096, MFG3101, MFG3107, MFG3127, MFG3138, MFG3164, MFG3174, MFG3193, MFG3203, MFG3217, MFG3228, MFG3234, MFG3239, MFG3258, MFG3264, MFG3277, MFG3302, MFG3112, MFG3331, MFG3373, MFG3354, MFG3382, MFG3387, MFG3394, MFG3399, MFG3427, MFG3431, MFG3463, MFG3482, MFG3498, MFG3519, MFG3521, MFG3555, MFG3583, MFG3572, MFG3622, MFG3653, MFG3676, MFG3734, MFG3742, MFG3755, MFG3758, MFG3762, MFG3801, MFG3802, MFG3839, MFG3861, MFG3870, MFG3876

Quantity recalled27090 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1113-2021
FDA event ID: 87084
Recalling firm: Combat Medical Systems, Harrisburg, NC
Classification: Class I
Status: Terminated
Recall initiated: 23 Dec 2020
FDA classified: 18 Feb 2021
Reported: 24 Feb 2021
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

23 Dec 2020	Recall initiated by company
18 Feb 2021	Classified by FDA	+57 days
24 Feb 2021	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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.

Where it was distributed

US Nationwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lot numbers: MFG2980, MFG3051, MFG3059, MFG3069, MFG3070, MFG3096, MFG3101, MFG3107, MFG3127, MFG3138, MFG3164, MFG3174, MFG3193, MFG3203, MFG3217, MFG3228, MFG3234, MFG3239, MFG3258, MFG3264, MFG3277, MFG3302, MFG3112, MFG3331, MFG3373, MFG3354, MFG3382, MFG3387, MFG3394, MFG3399, MFG3427, MFG3431, MFG3463, MFG3482, MFG3498, MFG3519, MFG3521, MFG3555, MFG3583, MFG3572, MFG3622, MFG3653, MFG3676, MFG3734, MFG3742, MFG3755, MFG3758, MFG3762, MFG3801, MFG3802, MFG3839, MFG3861, MFG3870, MFG3876

Where was it sold?

US Nationwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

4 other products · FDA event 87084

This product is part of a recall event; the main page for the event is Fresh Whole Blood Donor Set recalled by Combat Medical Systems.

Reported	Class	Recall	Company	Reason	Where
24 Feb 2021	CLASS I	Fresh Whole Blood Donor Set recalled by Combat Medical Systems	Combat Medical Systems	Other	Nationwide
24 Feb 2021	CLASS I	Valkyrie Ltowb Collection recalled by Combat Medical Systems	Combat Medical Systems	Other	Nationwide
24 Feb 2021	CLASS I	Valkyrie Ltowb Administration recalled by Combat Medical Systems	Combat Medical Systems	Other	Nationwide
24 Feb 2021	CLASS I	Low Titer Type O FWB Transfusion Set recalled by Combat Medical Systems	Combat Medical Systems	Other	Nationwide

More recalls from Combat Medical Systems

All 5

Reported	Class	Recall	Company	Reason	Where
24 Feb 2021Device	CLASS I	Low Titer Type O FWB Transfusion Set recalled by Combat Medical Systems	Combat Medical Systems	Other	Nationwide
24 Feb 2021Device	CLASS I	Valkyrie Ltowb Administration recalled by Combat Medical Systems	Combat Medical Systems	Other	Nationwide
24 Feb 2021Device	CLASS I	Valkyrie Ltowb Collection recalled by Combat Medical Systems	Combat Medical Systems	Other	Nationwide
24 Feb 2021Device	CLASS I	Fresh Whole Blood Donor Set recalled by Combat Medical Systems	Combat Medical Systems	Other	Nationwide

Other Other Medical Devices recalls

All 13,778

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16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide