The Recall Desk
ModerateFDA (Devices)·Z-0968-2019·Announced 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.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a functional difficulty rather than a reported injury, hospitalization, or structural defect leading to significant harm, fitting the Moderate criteria for a precautionary recall without reported adverse events.

Plain-English summary

Cook Inc. is recalling 975 units of the Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-3, Order Number G35570. The device is intended for anchoring the anterior wall of the stomach to the abdominal wall prior to the introduction of interventional catheters.

The recall is due to a potential for difficulty in sliding down the retention mechanism on sets manufactured with a specific extension spring lot. The affected lot numbers are 8056941, 8135292, 8165522, 8228910, 8261265, 8293447, 8331165, 8357394, 8389427, 8395982, 8445405, 8471250, 8483543, 8511203, 8556989, 8557006, 8564659, 8622758, 8628912, and 8663134.

The products were distributed nationwide in the United States to 22 states and internationally to 14 countries, including Austria, Belgium, Canada, Denmark, France, Germany, Great Britain, Hungary, Iceland, Italy, Netherlands, Norway, Spain, and Switzerland. Users should check their inventory for the affected lot numbers and contact Cook Inc. for further instructions.

The recalled product

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
Manufacturer
Cook Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
975

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lot numbers 8056941
  • 8135292
  • 8165522
  • 8228910
  • 8261265
  • 8293447
  • 8331165
  • 8357394
  • 8389427
  • 8395982
  • 8445405
  • 8471250
  • 8483543
  • 8511203
  • 8556989
  • 8557006
  • 8564659
  • 8622758
  • 8628912
  • 8663134

Distribution

Distributed nationwide across the United States.

The notice also names 21 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Cook Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

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