Z-0289-2017 Class II Terminated
FDA device recall Z-0289-2017 was initiated by US Endoscopy Group Inc on May 18, 2016 and is designated Class II. 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 c… The recall status is terminated (terminated May 10, 2017). Affected quantity: 36 units.
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