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Integra LifeSciences Corporation recalls Absorbable Collagen Sponge Provided As Intermediate to Another Company
Recalled May 22, 2013 · FDA recall Z-1302-2013 · 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
84,460 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
Absorbable Collagen Sponge Provided As Intermediate to Another Company
Manufacturer(s)
Integra LifeSciences Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →