Home / Recalls / Integra LifeSciences Corporation / Z-1290-2013

Z-1290-2013 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
14, 525 boxes

Product Description

Helitene Absorbable Collagen Hemostatic Sponge Helitene 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

1110788, 1112217 1110222, 1111357 1111602, 1105255 1110224, 1110225 1111601, 1110223 1110790, 1111603

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