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Terminated

Histolock Resection Device, US Endoscopy. An electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during gastrointestinal endoscopic procedures.

FDA Recall Z-0001-2016 · Posted 2015-10-01

Recalling FirmUS Endoscopy Group Inc
Recall StatusTerminated
Product CodeFDI
Date Initiated2015-07-14
Date Terminated2016-10-27
Product Quantity41 units

Reason for Recall

The company has determined the sterility cannot be assured for the affected lot.

Firm Action

The firm, US Endoscopy, sent an "URGENT: HISTOLOCK" RESECTION DEVICE RECALL" letter and response form to their customers on July 14, 2015. The letter described the product, problem and action to be taken. The customers were instructed to complete the response form and return to your US Endoscopy Product Specialist and retain a copy of the letter for your records. If you have any questions, contact Sr. Manager, Reg. Affairs & Quality Compliance at 440-358-6251 or email at: [email protected].

Root Cause

Employee error

Distribution Pattern

US Distribution to states of: AL, AR, CA, IL, IN, MS, OH, OK & TN.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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