Z-2313-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 14, 2017
- Initiation Date
- May 1, 2017
- Termination Date
- March 26, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 327 Lots, 725 units
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.
Reason for Recall
COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.
Distribution Pattern
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.
Code Information
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