Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Infinity sampling device, Cytology Brush

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Infinity sampling device, Cytology Brushsee related information
Date Initiated by FirmDecember 22, 2011
Date PostedSeptember 17, 2012
Recall Status1 Terminated 3 on March 22, 2013
Recall NumberZ-2396-2012
Recall Event ID 63047
510(K)NumberK103437 
Product Classification Endoscope and/or accessories - Product Code KOG
ProductInfinity 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.
FEI Number 1000122656
Recalling Firm/
Manufacturer		 US Endoscopy Group Inc
5976 Heisley Rd
Mentor OH 44060-1873
For Additional Information ContactCraig 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
ActionUS 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 Commerce393 Devices
DistributionWorldwide 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) Database510(K)s with Product Code = KOG
-
-