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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device

Combat Medical Systems, LLC: There is the potential of a bent or disconnected needle in one of the components of the convenience kits.

Agency Publication Date: February 19, 2021
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Affected Products

Product: 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

Lot Numbers:
Numbers
Product: 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

Lot Numbers:
Numbers
Product: 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

Lot Numbers:
Numbers
Product: 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

Lot Numbers:
numbers
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.

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

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87084
Status: Resolved
Manufacturer: Combat Medical Systems, LLC
Manufactured In: United States
Units Affected: 5 products (531 units; 953 units; 1021 units; 27090 units; 954 units)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.