Device product
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
Z-0289-2017
Product summary
- Event
- Event 74590
- Status
- Terminated
- Classification
- Class II
- Quantity
- 36 units
- Official record key
device-enforcement:Z-0289-2017
Official wording
Reason: 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.
Code information: Model #: 00711819; Lot 1520268
Distribution pattern: US Distribution to the states of : OH, OR, WA and Internationally to the country of Italy.
Derived failure modes
-
Unknown
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.