Infinity sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976 Heisley Road, Mentor, OH 44060 The I
FDA device recall Z-2396-2012 · posted 2012-09-17 · Terminated
Recall details
- Recalling firm
- US Endoscopy Group Inc
- Reason for recall
- US Endoscopy received five complaints which noted difficulty in deploying the cytology brush through the catheter.
- Action taken
- 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
- Status
- Terminated
- Product code
- KOG
- Quantity affected
- 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, It
- Date initiated
- 2011-12-22
- Date posted
- 2012-09-17
- Date terminated
- 2013-03-22
- Location
- Mentor, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| US ENDOSCOPY CYTOLOGY BRUSH (K103437) | United States Endoscopy Group, Inc. | 2010-12-23 |