Recall Z-0289-2017 ยท FBK Endoscopic Injection Needle, Gastroenterology-Urology
US Endoscopy Group Inc
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
| Date | Oct 19, 2016 (initiated May 18, 2016) |
| Status | Terminated |
| 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. |
| Root cause | Other |
| Action | US Endoscopy sent an Urgent- (Vari Safe) injection needle recall letter dated July 6, 2016. US Endoscopy requests that you: 1.Quarantine the affected Vari-Safe Injection devices in your stock. 2. Destroy each affected device by opening the device package, cutting the device catheter with a scissors, and then discarding the device and package. 3.Complete the attached Customer Response Card and return to the attention of US Endoscopy Customer Service, via fax 1-440-639-4495 or email orders@us endos copy.com . A no charge replacement will be provided for each unused Vari-Safe Injection Need |
| Quantity | 36 units |
| Distribution | US Distribution to the states of : OH, OR, WA and Internationally to the country of Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971842 | COAXIAL NEEDLE United States Endoscopy Group, Inc., Jun 20, 1997 |