Recall Z-2396-2012— US Endoscopy Group Inc

Name: FDA recall Z-2396-2012
Creator: U.S. Food and Drug Administration
Published: 2011-12-22

Class II · Terminated

Class II FDA medical device recall by US Endoscopy Group Inc, initiated 2011-12-22, terminated 2013-03-22. It names one FDA 510(k) clearance: K103437. 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.. Reason: US Endoscopy received five complaints which noted difficulty in deploying the cytology brush through the catheter..

Recalling firm: US Endoscopy Group Inc
Classification: Class II
Status: Terminated
Initiated: 2011-12-22
Terminated: 2013-03-22
Firm location: Mentor, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K103437 — US ENDOSCOPY CYTOLOGY BRUSHUnited States Endoscopy Group, Inc.·cleared 2010-12-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.