CollaCote Absorbable Collagen Wound Dressing Recalled for Pyrogen Levels
Integra LifeSciences is recalling CollaCote Absorbable Collagen Wound Dressings for dental surgery 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 a risk-of-harm product (pyrogens) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Integra LifeSciences Corporation is recalling 32,790 boxes of CollaCote Absorbable Collagen Wound Dressing for Dental Surgery. The product is intended for use on moist or bleeding oral wounds to help protect the wound surface and control bleeding. 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 nationwide in the United States (including Puerto Rico) and in 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. Specific lot codes involved in the recall include 1125684, 1125685, 1125689, 1126014, 1104963, 1110481, 1110791, 1110792, 1111363, 1111644, 1110673, and 1111856.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for instructions on how to proceed.
The recalled product
- Product
- CollaCote Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical
- Manufacturer
- Integra LifeSciences Corporation
- Category
- Medical Device — Wound Dressing
- Hazard
- Affected units
- 32,790
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)
- 1125684
- 1125685 1125689
- 1126014 1104963
- 1110481 1110791
- 1110792 1111363
- 1111644 1110673
- 1111856
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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