Combat Medical Systems Fresh Whole Blood Donor Set Recall: Bent Needle Risk
Combat Medical Systems recalls Fresh Whole Blood Donor Sets with potential bent or disconnected needles. Affected lots include MFG2977 through MFG3857. Stop using if you have these kits.
Use caution until it’s fixed
There is the potential of a bent or disconnected needle in one of the components of the convenience kits.
Contact the company
What happened, in plain English
Combat Medical Systems is recalling Fresh Whole Blood Donor Sets that may have bent or disconnected needles. This could cause injury during blood collection if the needle isn't properly attached. Read more at govinfonow.com/recall/63596-combat-medical-systems-fresh-whole-blood-donor-set-recall-bent.
Source Summary by GovInfoNow · govinfonow.com/recall/63596-combat-medical-systems-fresh-whole-blood-donor-set-recall-bent · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1114-2021
Cite this page
“Combat Medical Systems Fresh Whole Blood Donor Set Recall: Bent Needle Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63596-combat-medical-systems-fresh-whole-blood-donor-set-recall-bent. Based on FDA recall #Z-1114-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1114-2021%22&limit=1).
Why it’s dangerous
The kits may have a bent or disconnected needle during use. This could lead to injury if the needle isn't securely attached when drawing blood from a donor.
Who’s affected
Blood donors and healthcare professionals who use these kits are affected. Those collecting blood at home or in non-clinical settings are at higher risk.
How to tell if you have this one
Check the lot number on the kit, which is listed as MFG2977 through MFG3857. The product is a blood convenience kit for testing and collecting whole blood from donors.
- Brand
Combat Medical Systems- Category
Medical device
All 5 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class I- Status
Terminated- Distribution
US Nationwide Distribution
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1110-2021 | 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.; Lot Numbers: MFG3204, MFG3327, MFG3350, MFG3455, MFG3541, MFG3573, MFG3582, MFG3648, MFG3659, MFG3671 | 531 units |
| Z-1111-2021 | 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.; Lot Numbers: MFG3205, MFG3353, MFG3403, MFG3440, MFG3540, MFG3574, MFG3584, MFG3649, MFG3660, MFG3698 | 953 units |
| Z-1112-2021 | 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.; Lot Numbers: MFG2267, MFG2347, MFG2375, MFG2430, MFG2538, MFG2637, MFG2655, MFG2693, MFG2708, MFG2754, MFG2828, MFG3120, MFG3186, MFG3340, MFG3378, MFG3386, MFG3586, MFG3640 | 1021 units |
| Z-1113-2021 | 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.; 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 | 27090 units |
| Z-1114-2021 | 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.; Lot Numbers: MFG2977, MFG2991, MFG3073, MFG3118, MFG3279, MFG3328, MFG3332, MFG3337, MFG3339, MFG3499, MFG3507, MFG3512, MFG3533, MFG3704, MFG3751, MFG3761, MFG3760, MFG3857 | 954 units |
What to do — step by step
Check Kit Lot Number
Look for the lot number on the kit, which is one of MFG2977, MFG2991, MFG3073, MFG3118, MFG3279, MFG3328, MFG3332, MFG3337, MFG3339, MFG3499, MFG3507, MFG3512, MFG3533, MFG3704, MFG3751, MFG3761, MFG3760, or MFG3857.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 3.5 years after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1114-2021 (December 23, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1114-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.