The Recall Desk

FDA (Devices) recall action 76360

Cook Inc. recalled 7 products on 2017-03-08

The FDA (Devices) publishes a recall like this one as 7 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 7 pages.

Products
7
Announced
2017-03-08
Critical
0
Units
47,984

Why these products were recalled

Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay in procedure and blood loss from patients.

Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay in procedure and blood loss from patients.

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.

States named across these recalls

1–7 of 7

  • HighFDA (Devices)··2017-03-08

    Cook Inc. Recalls Check-Flo Performer Introducer Sets Due to Blood Loss Risk

    Cook Inc. is recalling 854 Check-Flo Performer Introducer Sets because a specific valve design is associated with increased reports of blood loss.

    Product
    Check-Flo Performer Introducer Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices.
    Category
    Distribution
    46 states
  • HighFDA (Devices)··2017-03-08

    Cook Inc. Recalls Check-Flo Introducer Devices Due to Blood Loss Reports

    Cook Inc. is recalling 29 Check-Flo Introducer Hausdorf-Lock Atrial devices worldwide due to increased reports of blood loss associated with the hemostatic valve design.

    Product
    Check-Flo Introducer Hausdorf-Lock Atrial, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices
    Category
    Distribution
    46 states
  • HighFDA (Devices)··2017-03-08

    Cook Inc. Recalls Check-Flo Hemostasis Assemblies Due to Blood Loss Reports

    Cook Inc. is recalling 1,589 Check-Flo Hemostasis Assemblies because reports indicate increased blood loss associated with the device's valve design.

    Product
    Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch.
    Category
    Distribution
    46 states
  • HighFDA (Devices)··2017-03-08

    Cook Inc. Recalls Check-Flo Performer Introducers Due to Blood Loss Reports

    Cook Inc. is recalling 884 Check-Flo Performer Introducers because a specific valve design is associated with increased reports of blood loss.

    Product
    Check-Flo Performer Introducer, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices.
    Category
    Distribution
    46 states
  • HighFDA (Devices)··2017-03-08

    Cook Inc. Recalls TriForce Peripheral Crossing Sets Due to Blood Loss Reports

    Cook Inc. is recalling 1,875 TriForce Peripheral Crossing Sets because a specific valve design is associated with increased reports of blood loss.

    Product
    TriForce Peripheral Crossing Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The TriForce Peripheral Crossing Set is intended to be percutaneously introduced into blood vessels and support a wire guide while performing percutaneous peripheral…
    Category
    Distribution
    46 states
  • HighFDA (Devices)··2017-03-08

    Cook Inc. Recalls Micropuncture Check-Flo Performer Introducer Sets Due to Blood Loss

    Cook Inc. is recalling 778 Micropuncture Check-Flo Performer Introducer Sets because a specific valve design is associated with increased reports of blood loss.

    Product
    Micropuncture Check-Flo Performer Introducer Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices
    Category
    Distribution
    46 states
  • HighFDA (Devices)··2017-03-08

    Cook Inc. Recalls Flexor Radial Access Sets Due to Blood Loss Reports

    Cook Inc. is recalling 41,975 Flexor Radial Access Sets because a specific hemostatic valve design is associated with increased reports of blood loss.

    Product
    Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures
    Category
    Distribution
    46 states