FDAClass IISeptember 26, 2012

Infinity¿ sampling device recall

Infinity¿ sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976 Heisley Road, Mentor, OH 44060 The Infinity sampling device is a…

Why was Infinity¿ sampling device recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot numbers 49680, 50793, 50794, 50795, 52577 & 53023.

Product
Infinity¿ sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976 Heisley Road, Mentor, OH 44060 The Infinity sampling device is a…
Recalling firm
US Endoscopy Group Inc
Quantity
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.
Recall date
September 26, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls