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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot numbers 49680, 50793, 50794, 50795, 52577 & 53023.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- US Endoscopy Group Inc
- Reason for Recall:
- US Endoscopy received five complaints which noted difficulty in deploying the cytology brush through the catheter.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
Lot numbers 49680, 50793, 50794, 50795, 52577 & 53023.
Distribution:
Distributed in: CA, FL, GA, IA, IL, MA, ME, MN, MO, NC, NH, OH, OK, PA, TN, TX, VA, WA, WV
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2396-2012
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