Z-2538-2017 Class II Terminated
FDA device recall Z-2538-2017 was initiated by Cook Inc. on April 25, 2017 and is designated Class II. Reason for recall: reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products The recall status is terminated (terminated March 26, 2019). Affected quantity: 46.
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
- 46
Product Description
Endoscopic Introducer/Extractor
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-EIE-051500