Z-0968-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 6, 2019
- Initiation Date
- December 19, 2018
- Termination Date
- April 28, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 975
Product Description
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.
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.
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.
Code Information
Lot numbers 8056941,8135292, 8165522, 8228910, 8261265, 8293447, 8331165, 8357394, 8389427,8395982, 8445405, 8471250, 8483543, 8511203, 8556989, 8557006, 8564659, 8622758, 8628912, 8663134