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Recall Observatory FDA recall evidence

Device product

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.

Z-2396-2012

December 22, 2011

Class II

Product summary

Firm
US Endoscopy Group Inc
Event
Event 63047
Status
Terminated
Classification
Class II
Quantity
393 Devices
Official record key
device-enforcement:Z-2396-2012

Official wording

Reason: US Endoscopy received five complaints which noted difficulty in deploying the cytology brush through the catheter.

Code information: Lot numbers 49680, 50793, 50794, 50795, 52577 & 53023.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    US Endoscopy received five complaints which noted difficulty in deploying the cytology brush through the catheter.