Infinity sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976 Heisley Road, Mentor, OH 44060 The Infinity sampling device is a disposable cytology brush used to retrieve cytological cell samples in the gastrointestinal tract.
FDA Recall Z-2396-2012 · Posted 2012-09-17
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Recalling FirmUS Endoscopy Group Inc
Recall StatusTerminated
Product CodeKOG
Date Initiated2011-12-22
Date Terminated2013-03-22
Product Quantity393 Devices
Reason for Recall
US Endoscopy received five complaints which noted difficulty in deploying the cytology brush through the catheter.
Firm Action
US Endoscopy sent an Addendum and Correction to the Instructions for Use letter dated December 22, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to rinse the brush head with sterile water immediately prior to use (reference the attached Addendum. Customers were also instructed to retract and deploy the brush to ensure that is is functioning properly prior to use. Customers were asked to review the instruction for use for this product along with the Addendum to ensure proper usage and performance.
For questions customers should call 1-410-639-4494 or their local Endoscopic Product Specialist.
For questions regarding this recall call 440-639-4494, ext 378.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution - USA including CA, FL, GA, IA, IL, MA, ME, MN, MO, NC, NH, OH, OK, PA, TN, TX, VA, WA & WV and the countries of Australia, Canada, Columbia, Finland, Germany, India, Israel, Italy, Netherlands, New Zealand & United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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