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Recall Observatory FDA recall evidence

Device 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.

Z-1113-2021

December 23, 2020

Class I

Product summary

Firm
Combat Medical Systems, LLC
Event
Event 87084
Status
Terminated
Classification
Class I
Quantity
27090 units
Official record key
device-enforcement:Z-1113-2021

Official wording

Reason: 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

Derived failure modes

  • 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.