Integra Recalls Helitene Absorbable Collagen Hemostatic Sponge
Integra LifeSciences is recalling Helitene Absorbable Collagen Hemostatic Sponge because process deviations may have resulted in higher levels of pyrogens than permitted.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a process deviation leading to potential pyrogen levels above specifications, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Integra LifeSciences Corporation is recalling 14,525 boxes of Helitene Absorbable Collagen Hemostatic Sponge. The product 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.
The recall was initiated due to a process deviation that may have caused the affected product lots to be released with higher levels of pyrogens than permitted by the product specifications.
The affected lots were distributed worldwide, including the United States (nationwide) and Puerto Rico, as well as countries such as the Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa. The specific lot codes involved are 1110788, 1112217, 1110222, 1111357, 1111602, 1105255, 1110224, 1110225, 1111601, 1110223, 1110790, and 1111603.
The recalled product
- 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.
- Manufacturer
- Integra LifeSciences Corporation
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- 1110788
- 1112217 1110222
- 1111357 1111602
- 1105255 1110224
- 1110225 1111601
- 1110223 1110790
- 1111603
Distribution
Part of a larger recall action
This product is one of 21 recalled by Integra LifeSciences Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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