FDAFDA · Food and drugs·Recall number Z-2396-2012
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.
Published September 26, 2012 · Recall initiated: December 22, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
US Endoscopy received five complaints which noted difficulty in deploying the cytology brush through the catheter.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- US Endoscopy Group Inc
- Distributor
- 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.
- Lot
- Lot numbers 49680, 50793, 50794, 50795, 52577 & 53023.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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