Integra LifeSciences Corporation recalls OraTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surg

Recalled May 22, 2013 · FDA recall Z-1296-2013 · Integra LifeSciences

Hazard

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. · FDA Class II

Units

17,110 boxes

Sold at

Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.

Description

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Product

OraTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.

Manufacturer(s)

Integra LifeSciences Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →