FDA Device Recall Z-0001-2016: US Endoscopy Group Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0001-2016.

Recall Res Number

Z-0001-2016

Recalling Firm / Manufacturer

US Endoscopy Group Inc

FEI Number

1000122656

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2015-07-14

Date Posted

2015-10-01

Date Terminated

2016-10-27

Product Code

FDI

Event Number

71987

Product Quantity

41 units

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

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

Action Details 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: ccochara@usendoscopy.com.

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

Code Information / Serial Numbers M/N: 00711117; Lot #: 1505956

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Medical Device Recall: Z-0001-2016

Recall Parameters & Description

Related Establishments / Registrations

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