Integra Recalls Helistat Absorbable Hemostatic Due to Pyrogen Levels
Integra LifeSciences is recalling 24,342 boxes of Helistat Absorbable Hemostatic 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 is classified as FDA Class II, and the hazard involves pyrogens (fever-inducing substances) in a medical device, which poses a risk of harm without reported fatalities or serious injuries, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Integra LifeSciences Corporation is recalling 24,342 boxes of Helistat Absorbable Hemostatic, a collagen-based product used as an adjunct to hemostasis in surgical procedures. The recall is due to a process deviation that may have caused the product lots to be released with higher levels of pyrogens than permitted by the product specifications.
The affected product was distributed worldwide, including the United States (nationwide and Puerto Rico) and 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 1104789, 1104790, 1110793, 1112248, 1110248, and 1111867.
This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. Healthcare providers and facilities should check their inventory for the affected lot codes and stop using the product if it matches the recalled lots.
The recalled product
- Product
- 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.
- Manufacturer
- Integra LifeSciences Corporation
- Hazard
- Affected units
- 24,342
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 (3)
- 1104789 1104790
- 1110793 1112248
- 1110248 1111867
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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