Devices

Device Recall Helitene Absorbable Collagen Hemostatic Sponge

Model / Serial
1110788, 1112217 1110222, 1111357 1111602, 1105255 1110224, 1110225 1111601, 1110223 1110790, 1111603
Product Classification
General and Plastic Surgery Devices
Device Class
3
Implanted device?
Yes
Distribution
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.
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.
Manufacturer
Integra LifeSciences Corporation
1 Event
- Recall of Device Recall Helitene Absorbable Collagen Hemostatic Sponge

Manufacturer

Integra LifeSciences Corporation

Manufacturer Address
Integra LifeSciences Corporation, 105 Morgan Ln, Plainsboro NJ 08536-3339
Manufacturer Parent Company (2017)
Integra LifeSciences Holdings Corporation
Source
USFDA

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