Outer cardboard box labeling: Pinnacle Cure Sleeve recall: Contamination
Outer cardboard box labeling: Pinnacle Cure Sleeve, Curing Light Tip Sleeves. Kerr Total Care. Part Number: 4513C or 4513-1 Single Patient Use Fits…
Why was Outer cardboard box labeling: Pinnacle Cure Sleeve 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part Number: 4513C or 4513-1. Lot Number: 2014030110
- 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…
- Recalling firm
- Sybron Dental Specialties
- Quantity
- 172
- Distribution
- Worldwide distribution. US Nationwide, Canada, Australia, Netherlands, Switzerland, Japan,
- Recall date
- March 25, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)