FDAClass IIMarch 6, 2019

Entuit Secure Gastrointestinal Suture Anchor Set recall

Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-2, Order Number G35569 The Entuit Secure Gastrointestinal Suture Anchor Set…

Why was Entuit Secure Gastrointestinal Suture Anchor Set recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-2, Order Number G35569 The Entuit Secure Gastrointestinal Suture Anchor Set…
Recalling firm
Cook Inc.
Quantity
797
Distribution
Worldwide Distribution: US (nationwide) to of states: AL, AZ, CA, GA, HI, IL, IN, KY, LA, MI, MN, MO, NC, NJ, NY, OH, PA, RI, TN, TX, and UT; and countries of: Austria, Belgium, Canada, Denmark, France, Germany, Great Britain, Hungary, Iceland, Italy, Netherlands, Norway, Spain, and Switzerland.
Recall date
March 6, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls