Sybron Dental Specialties recalls Outer cardboard box labeling: Pinnacle Cure Sleeve, Curing Light Tip Sleeves. Kerr Total Care. Part Number: 4513C or 45…

Recall date

February 11, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1291-2015

FDA classification

Class II

Brand / firm

Sybron Dental Specialties

Sold / distributed

Worldwide distribution. US Nationwide, Canada, Australia, Netherlands, Switzerland, Japan,

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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