The Recall Desk

FDA (Devices) recall action 88787

Cook Inc. recalled 2 products on 2021-11-10

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2021-11-10
Critical
0
Units
96

Why these products were recalled

Affected lots may be manufactured incorrectly with the radiopaque marker band located just below the Check-Flo proximal fitting instead of the distal tip. The issue may not be identified until the device is placed in the patient and viewed under fluoroscopy, leading to increased procedural time.

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

1–2 of 2

  • HighFDA (Devices)··2021-11-10

    Flexor Check-Flo Introducer Sets recalled due to misplaced radiopaque marker band

    Cook Inc. recalls Flexor Check-Flo Introducer Sets where the radiopaque marker band is incorrectly positioned, which may not be discovered until the device is used in a patient under fluoroscopy, increasing procedural time.

    Product
    Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-38-90-RB-RAABE, GPN G13069 The introducer sheath incorporates a hydrophilic coated Flexor shaft with a hemostasis valve and is provided with a dilator.
    Category
    Distribution
    17 states
  • ModerateFDA (Devices)··2021-11-10

    Flexor Check-Flo Introducer recalled for misplaced radiopaque marker

    Cook Inc. is recalling one lot of Flexor Check-Flo Introducers due to a manufacturing defect where the radiopaque marker band may be positioned incorrectly, affecting visualization during medical procedures.

    Product
    Flexor Check-Flo Introducer, Introducer Set, RPN KCFW-6.0-35-45-RB, GPN G09908 The introducer sheath incorporates a hydrophilic coated Flexor shaft with a hemostasis valve and is provided with a dilator.
    Category
    Distribution
    17 states