device · product 1 of 1
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
- Recall number
- Z-0289-2017
- Initiated
- May 18, 2016
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- US Endoscopy Group Inc
- Quantity
- 36 units
App-derived interpretation
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.
Official device-enrichment evidence · Sourced
Other
Inspect official wording and provenance
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.
Code information
Model #: 00711819; Lot 1520268
Distribution pattern
US Distribution to the states of : OH, OR, WA and Internationally to the country of Italy.