Integra LifeSciences Corporation recalls Helistat Absorbable Hemostatic,Collagen Based Helistat is indicated in surgical procedures (other than ophthalmologic

Recalled May 22, 2013 · FDA recall Z-1289-2013 · 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

24,342 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

Helistat Absorbable Hemostatic,Collagen Based Helistat is indicated in surgical procedures (other than ophthalmological and urological surgery) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.

Manufacturer(s)

Integra LifeSciences Corporation

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