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U.S. Department of Health and Human Services

Class 2 Device Recall Infinity sampling device, Cytology Brush

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  Class 2 Device Recall Infinity sampling device, Cytology Brush see related information
Date Initiated by Firm December 22, 2011
Date Posted September 17, 2012
Recall Status1 Terminated 3 on March 22, 2013
Recall Number Z-2396-2012
Recall Event ID 63047
510(K)Number K103437  
Product Classification Endoscope and/or accessories - Product Code KOG
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.
Code Information Lot numbers 49680, 50793, 50794, 50795, 52577 & 53023.
Recalling Firm/
Manufacturer		 US Endoscopy Group Inc
5976 Heisley Rd
Mentor OH 44060-1873
For Additional Information Contact Craig L. Moore
440-639-4494 Ext. 378
Manufacturer Reason
for Recall		 US Endoscopy received five complaints which noted difficulty in deploying the cytology brush through the catheter.
FDA Determined
Cause 2		 Nonconforming Material/Component
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.
Quantity in Commerce 393 Devices
Distribution 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.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KOG and Original Applicant = UNITED STATES ENDOSCOPY GROUP, INC.
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