Device product
Outer cardboard box labeling: Pinnacle Cure Sleeve, Curing Light Tip Sleeves. Kerr Total Care. Part Number: 4513C or 4513-1 Single Patient Use Fits 13mm Tips. Pack of 400. Metrex Research, Manufacturer. Inner individual packaging of each sleeve: Cure Sleeve by Pinnacle Model 4500
Z-1291-2015
Product summary
- Event
- Event 70551
- Status
- Terminated
- Classification
- Class II
- Quantity
- 172
- Official record key
device-enforcement:Z-1291-2015
Official wording
Reason: 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.
Code information: Part Number: 4513C or 4513-1. Lot Number: 2014030110
Distribution pattern: Worldwide distribution. US Nationwide, Canada, Australia, Netherlands, Switzerland, Japan,
Derived failure modes
-
Unknown
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.