The Recall Desk
ModerateFDA (Devices)·Z-0967-2019·Announced 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.

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, and the hazard is a functional difficulty with the retention mechanism rather than a direct injury or contamination, fitting the criteria for moderate severity.

Plain-English summary

Cook Inc. is recalling 797 units of the Entuit Secure Gastrointestinal Suture Anchor Set (Catalog Number GIAS-SRM-2, Order Number G35569). 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 difficulty in sliding down the retention mechanism on sets manufactured with a specific extension spring lot. The affected units were distributed nationwide in the United States and in several countries including Austria, Belgium, Canada, Denmark, France, Germany, Great Britain, Hungary, Iceland, Italy, Netherlands, Norway, Spain, and Switzerland.

Healthcare providers and patients should stop using the affected devices and contact Cook Inc. for further instructions. The recall covers specific lot numbers including 8144390, 8159665, 8173295, 8204594, 8261263, 8294836, 8308856, 8331166, 8395981, 8459751, 8471244, 8511162, 8535303, 8541938, 8574041, 8582863, 8597539, 8541938X, and 8582863X.

The recalled product

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
Manufacturer
Cook Inc.
Category
Medical Device — Surgical Instrument
Hazard
Affected units
797

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 (19)

  • Lot numbers 8144390
  • 8159665
  • 8173295
  • 8204594
  • 8261263
  • 8294836
  • 8308856
  • 8331166
  • 8395981
  • 8459751
  • 8471244
  • 8511162
  • 8535303
  • 8541938
  • 8574041
  • 8582863
  • 8597539
  • 8541938X
  • 8582863X

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 →

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