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.
Enforcement
- Recall Number
- Z-2313-2017
- Event ID
- 77167
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Cook Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 14, 2017
- Initiation Date
- May 1, 2017
- Classification Date
- June 7, 2017
- Termination Date
- March 26, 2019
- Address
- 750 N Daniels Way, N/A, Bloomington, IN, 47404-9120, United States
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.
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.
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
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.
327 Lots, 725 units