Devices

Device Recall Endoscopic Curved Needle

Model / Serial
CATALOG NUMBER: and GPN: J-ENH-033100 & G16426, J-ENH-053100 & G16427, J-ENH-053120 & G16428, J-ENH-053130 & G16429 Dates of Manufacture: January 2012 to February 2017
Product Classification
Gastroenterology-Urology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution - US (nationwide) and countries of: Australia, Austria, Belgium, Bahrain, Canada, China, Costa Rica, Finland, France, Germany, Hong Kong, India, Ireland, Italy, Lithuania, Latvia, Malaysia, Netherlands, Romania, Russia, Saudi Arabia, Singapore, Spain, Switzerland, United Arab Emirates, and United Kingdom.
Product Description
Endoscopic Curved Needle, Surgical Needle Guide, Supplied sterilized by ethylene oxide gas in peel-open packages. || Used for internal suturing under direct vision during intraabdominal endoscopic procedures. The needle driver design affords precise placement and control of standard curved suture needles, similar to open abdominal suturing.
Manufacturer
Cook Inc.
1 Event
- Recall of Device Recall Endoscopic Curved Needle

Manufacturer

Cook Inc.

Manufacturer Address
Cook Inc., 750 N Daniels Way, Bloomington IN 47404-9120
Manufacturer Parent Company (2017)
Cook Group Incorporated
Source
USFDA

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

Stories in your inbox

Do you work in the medical industry? Or have experience with a medical device? Our reporting is not done yet. We want to hear from you.

Tell us your story!

Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

Download the data

The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

Download all (zipped)