Recall Z-1290-2013— Integra LifeSciences Corporation
Class II · Terminated
Class II FDA medical device recall by Integra LifeSciences Corporation, initiated 2013-03-28, terminated 2015-06-03. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..
- Recalling firm
- Integra LifeSciences Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-03-28
- Terminated
- 2015-06-03
- Firm location
- Plainsboro, NJ, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.