Device product
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.
Z-2313-2017
Product summary
- Firm
- Cook Inc.
- Event
- Event 77167
- Status
- Terminated
- Classification
- Class II
- Quantity
- 327 Lots, 725 units
- Official record key
device-enforcement:Z-2313-2017
Official wording
Reason: 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.
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
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.
Derived failure modes
-
Unknown
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.