FDA-Device2015-10-07Class IIPACKAGING DEFECT
US Endoscopy Histolock Resection Device recalled for sterility concerns
Stop using US Endoscopy Histolock devices
US Endoscopy Group Inc recalled Histolock Resection Devices used during gastrointestinal endoscopic procedures because the company cannot confirm these devices are sterile. The recall affects 41 units in specific states. No injuries have been reported.
- If you have a Histolock device with lot number 1505956, stop using it immediately
- Contact your healthcare facility or US Endoscopy Group Inc for instructions on return or replacement
- Inform your healthcare provider if you received a procedure using an affected device
Hazard
The company has determined the sterility cannot be assured for the affected lot.
Sold states
US Distribution to states of: AL, AR, CA, IL, IN, MS, OH, OK & TN.
Affected count
41 units
Manufactured in
5976 Heisley Rd, N/A, Mentor, OH, United States
Products
Histolock Resection Device, US Endoscopy. An electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during gastrointestinal endoscopic procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0001-2016Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief