Exact FDA event identifier

Event 87084

5 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: December 23, 2020
Product types: Device
Classifications: Class I
Statuses: Terminated
Recalling firm wording: Combat Medical Systems, LLC

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

5 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 5

Valkyrie LTOWB Collection (P/N 80-820, NSN 6515016862423). Blood collection convenience kit. The Valkyrie LTOWB Collection Set includes the items needed to allow for pre-screening to identify Low Titer Type O Donors as well as collect the blood from the donor.

Z-1110-2021

Recall number: Z-1110-2021
Initiated: December 23, 2020
Classification: Class I
Status: Terminated
Recalling firm: Combat Medical Systems, LLC
Quantity: 531 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot Numbers: MFG3204, MFG3327, MFG3350, MFG3455, MFG3541, MFG3573, MFG3582, MFG3648, MFG3659, MFG3671

Distribution pattern

US Nationwide Distribution

device · product 2 of 5

Valkyrie LTOWB Administration (P/N 80-821 NSN 6515016862401). Blood convenience kit. The Valkyrie LTOWB Administration Set contains the items needed to administer the blood to the patient.

Z-1111-2021

Recall number: Z-1111-2021
Initiated: December 23, 2020
Classification: Class I
Status: Terminated
Recalling firm: Combat Medical Systems, LLC
Quantity: 953 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot Numbers: MFG3205, MFG3353, MFG3403, MFG3440, MFG3540, MFG3574, MFG3584, MFG3649, MFG3660, MFG3698

Distribution pattern

US Nationwide Distribution

device · product 3 of 5

Low Titer Type O FWB Transfusion Set (P/N 80-875 NSN 651501684994). Blood convenience kit. The Transfusion Set includes the items necessary to administer the collected blood to a patient.

Z-1112-2021

Recall number: Z-1112-2021
Initiated: December 23, 2020
Classification: Class I
Status: Terminated
Recalling firm: Combat Medical Systems, LLC
Quantity: 1021 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot Numbers: MFG2267, MFG2347, MFG2375, MFG2430, MFG2538, MFG2637, MFG2655, MFG2693, MFG2708, MFG2754, MFG2828, MFG3120, MFG3186, MFG3340, MFG3378, MFG3386, MFG3586, MFG3640

Distribution pattern

US Nationwide Distribution

device · product 4 of 5

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.

Z-1113-2021

Recall number: Z-1113-2021
Initiated: December 23, 2020
Classification: Class I
Status: Terminated
Recalling firm: Combat Medical Systems, LLC
Quantity: 27090 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

US Nationwide Distribution

device · product 5 of 5

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.

Z-1114-2021

Recall number: Z-1114-2021
Initiated: December 23, 2020
Classification: Class I
Status: Terminated
Recalling firm: Combat Medical Systems, LLC
Quantity: 954 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot Numbers: MFG2977, MFG2991, MFG3073, MFG3118, MFG3279, MFG3328, MFG3332, MFG3337, MFG3339, MFG3499, MFG3507, MFG3512, MFG3533, MFG3704, MFG3751, MFG3761, MFG3760, MFG3857

Distribution pattern

US Nationwide Distribution