The Recall Desk

FDA (Devices) recall action 87084

Combat Medical Systems, LLC recalled 5 products on 2021-02-24

The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2021-02-24
Critical
1
Units
30,549

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–5 of 5

  • SevereFDA (Devices)··2021-02-24

    Combat Medical Systems Recalls Fresh Whole Blood Transfusion Sets

    Combat Medical Systems is recalling Fresh Whole Blood Transfusion Sets due to a potential for bent or disconnected needles in the kit components.

    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.
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2021-02-24

    Combat Medical Systems Recalls Low Titer Type O FWB Transfusion Sets

    Combat Medical Systems, LLC is recalling 1021 units of Low Titer Type O FWB Transfusion Sets due to the potential for bent or disconnected needles in the components.

    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.
    Category
    Distribution
    0 states
  • CriticalFDA (Devices)··2021-02-24

    Combat Medical Systems Recalls Fresh Whole Blood Donor Sets

    Combat Medical Systems is recalling 954 Fresh Whole Blood Donor Sets due to a potential bent or disconnected needle in the kit components.

    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.
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2021-02-24

    Combat Medical Systems Recalls Valkyrie LTOWB Blood Collection Kits

    Combat Medical Systems is recalling 531 Valkyrie LTOWB blood collection kits due to a potential for bent or disconnected needles.

    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.
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2021-02-24

    Combat Medical Systems Recalls Valkyrie LTOWB Blood Administration Kits

    Combat Medical Systems is recalling 953 Valkyrie LTOWB Administration Sets due to a potential for bent or disconnected needles.

    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.
    Category
    Distribution
    0 states