Home / Recalls / Integra LifeSciences Corporation / Z-1289-2013

Z-1289-2013 Class II Terminated

Recalled by Integra LifeSciences Corporation — Plainsboro, NJ

Recall Details

Product Type
Devices
Report Date
May 22, 2013
Initiation Date
March 28, 2013
Termination Date
June 3, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
24,342 boxes

Product Description

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.

Reason for Recall

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.

Distribution Pattern

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.

Code Information

1104789 1104790, 1110793 1112248, 1110248 1111867

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