The Recall Desk

FDA (Devices) recall action 81979

Cook Inc. recalled 2 products on 2019-03-06

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
2019-03-06
Critical
0
Units
1,772

Why these products were recalled

There is a potential for difficulty in sliding down the retention mechanism on the sets manufactured with a specific extension spring lot.

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)··2019-03-06

    Cook Inc. Recalls Gastrointestinal Suture Anchor Sets Due to Retention Mechanism Issue

    Cook Inc. is recalling 975 Entuit Secure Gastrointestinal Suture Anchor Sets because a specific extension spring lot may cause difficulty sliding down the retention mechanism.

    Product
    Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-3, Order Number G35570 The Entuit Secure Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of the stomach to the abdominal wall prior to the introduction of interventional ca
    Category
    Distribution
    21 states
  • ModerateFDA (Devices)··2019-03-06

    Cook Inc. Recalls Gastrointestinal Suture Anchor Sets Due to Retention Mechanism Issue

    Cook Inc. is recalling 797 Entuit Secure Gastrointestinal Suture Anchor Sets because a specific extension spring lot may cause difficulty sliding the retention mechanism.

    Product
    Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-2, Order Number G35569 The Entuit Secure Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of the stomach to the abdominal wall prior to the introduction of interventional ca
    Category
    Distribution
    21 states