Exact FDA event identifier

Event 81979

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: December 19, 2018
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Cook Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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 catheters.

Z-0967-2019

Recall number: Z-0967-2019
Initiated: December 19, 2018
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 797

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

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.

device · product 2 of 2

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 catheters.

Z-0968-2019

Recall number: Z-0968-2019
Initiated: December 19, 2018
Classification: Class II
Status: Terminated
Recalling firm: Cook Inc.
Quantity: 975

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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