Z-2537-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 21, 2017
- Initiation Date
- April 25, 2017
- Termination Date
- March 26, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 178
Product Description
Clarke-Reich Laparoscopic Knot Pusher
Reason for Recall
reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
Distribution Pattern
The devices have been distributed nationwide within the United States and the following countries: Australia, Belgium, Canada, Finland, Germany, Guatemala, Hong Kong, India, Ireland, Japan, South Korea, Kuwait, Malaysia, Netherlands, New Zealand, Puerto Rico, Saudi Arabia, Taiwan, and the United Kingdom.
Code Information
All lots Catalog numbers: J-CRKP-042900