Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 A sterile, single use, flexible sheath devi

FDA device recall Z-0289-2017 · posted 2016-10-19 · Terminated

Recall details

Recalling firm

US Endoscopy Group Inc

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

FBK

Quantity affected

36 units

Distribution

US Distribution to the states of : OH, OR, WA and Internationally to the country of Italy.

Date initiated

2016-05-18

Date posted

2016-10-19

Date terminated

2017-05-10

Location

Mentor, OH

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