The Recall Desk

FDA (Devices) recall action 89072

Cook Inc. recalled 2 products on 2021-12-22

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
2021-12-22
Critical
0
Units
97

Why these products were recalled

Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa

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

  • ModerateFDA (Devices)··2021-12-22

    Flexor Check-Flo Introducer Recalled for Mislabeled Caliber Size

    Cook Inc. is recalling Flexor Check-Flo Introducer devices due to mislabeling where packages marked as 6FR may contain 7FR devices, or vice versa. This sizing mismatch could result in improper device selection during clinical vascular procedures.

    Product
    Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44155 Intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Distribution
    15 states
  • HighFDA (Devices)··2021-12-22

    Cook Flexor Check-Flo Introducer recalled for size mislabeling

    Cook Inc. is recalling the Flexor Check-Flo Introducer due to mislabeled packaging where 6FR devices may be labeled as 7FR or vice versa. This size mislabeling could result in selection of the wrong device size.

    Product
    Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-6.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44154 Intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Distribution
    15 states