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Recall Observatory FDA recall evidence

Device product

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

Z-0001-2016

July 14, 2015

Class II

Product summary

Firm
US Endoscopy Group Inc
Event
Event 71987
Status
Terminated
Classification
Class II
Quantity
41 units
Official record key
device-enforcement:Z-0001-2016

Official wording

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

Code information: M/N: 00711117; Lot #: 1505956

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

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    sterility cannot be assured