FDA-Device2013-05-22Class II
Absorbable Collagen Sponge Provided As Intermediate to Another Company
Integra LifeSciences Corporation
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.
Sold states
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.
Affected count
84,460 boxes
Manufactured in
105 Morgan Ln, Plainsboro, NJ, United States
Products
Absorbable Collagen Sponge Provided As Intermediate to Another Company
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1302-2013Don't want to check this manually?
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