Reported Sep 26, 2012 · Terminated
Infinity¿ sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976 Heisley Road, Mentor, OH 44060 The…
US Endoscopy Group Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: US Endoscopy Group Inc · 5976 Heisley Rd · Mentor, OH · 44060-1873
Is this the product you have?
- 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.
- Lot codes and dates
Lot numbers 4968050793507945079552577 & 53023
- Amount recalled
- 393 Devices
Where it was sold
Why it was recalled
US Endoscopy received five complaints which noted difficulty in deploying the cytology brush through the catheter.
This product could cause temporary or reversible health problems — stop using it.
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