Reported Mar 25, 2015 · Terminated
Outer cardboard box labeling: Pinnacle Cure Sleeve, Curing Light Tip Sleeves. Kerr Total Care. Part Number: 4513C or…
Sybron Dental Specialties
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: Sybron Dental Specialties · 1717 W Collins Ave · Orange, CA · 92867-5422
Is this the product you have?
- Outer cardboard box labelingPinnacle Cure Sleeve, Curing Light Tip Sleeves. Kerr Total Care
- Part Number4513C or 4513-1 Single Patient Use Fits 13mm Tips. Pack of 400. Metrex Research, Manufacturer. Inner
- individual packaging of each sleeveCure Sleeve by Pinnacle Model 4500
- Lot codes and dates
- Part Number4513C or 4513-1
- Lot Number2014030110
- Amount recalled
- 172
Where it was sold
- Nationwide
Why it was recalled
Cases of Cure Sleeve labeled with part number 4513, which fits 13mm tips, have inner boxes labeled with part number 4500 which fit 7mm and 8mm tips. There is a low risk associated with the use of the product as the sleeve may tear causing a potential for cross contamination.
This product could cause temporary or reversible health problems — stop using it.
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