Class 2 Device Recall VariSafe

• Date Initiated by Firm: May 18, 2016
• Date Posted: October 19, 2016
• Recall Status: Terminated on May 10, 2017
• Recall Number: Z-0289-2017
• Recall Event ID: 74590
• 510(K)Number: K971842
• Product Classification: endoscopic injection needle, gastroenterology-urology - Product Code FBK
• 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
• Code Information: Model #: 00711819; Lot 1520268
• FEI Number: 1000122656
• Recalling Firm/ Manufacturer: US Endoscopy Group Inc; 5976 Heisley Rd; Mentor OH 44060-1873
• For Additional Information Contact: Ms. Kia (NMI) Pennington; 800-769-8226
• Manufacturer 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.
• FDA Determined 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 Needle device from the affected lot. We apologize for any inconvenience this matter may cause you, and as always, US Endoscopy is dedicated to supporting our products and valued Customers. For further questions please call (800) 769-8226.
• Quantity in Commerce: 36 units
• Distribution: US Distribution to the states of : OH, OR, WA and Internationally to the country of Italy.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FBK