Z-2314-2017 Class II Terminated
FDA device recall Z-2314-2017 was initiated by Cook Inc. on May 1, 2017 and is designated Class II. 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 sterilizatio… The recall status is terminated (terminated March 26, 2019). Affected quantity: 327 lots, 288 units.
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, 288 units
Product Description
Reason for Recall
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.