Z-0289-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 26, 2016
- Initiation Date
- May 18, 2016
- Termination Date
- May 10, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 36 units
Product Description
Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 A sterile, single use, flexible sheath device intended to be used for the injection of various types of media through flexible endoscopes
Reason for Recall
US Endoscopy is conducting a voluntary product recall of one lot of the Vari-Safe Injection Needle as it was identified that the lot was incorrectly distributed. The lot was assembled with internal catheter components which differ from the original Vari-Safe needle internal catheter components. All components are dimensionally similar to the original Vari-Safe needle internal catheter components and the components have history of use on other US Endoscopy needle products.
Distribution Pattern
US Distribution to the states of : OH, OR, WA and Internationally to the country of Italy.
Code Information
Model #: 00711819; Lot 1520268