Integra HeliTape Collagen Wound Dressing Recalled for Pyrogen Levels
Integra LifeSciences is recalling HeliTape Absorbable Collagen Wound Dressings for dental surgery due to potential pyrogen levels exceeding specifications.
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 19,030 boxes of HeliTape Absorbable Collagen Wound Dressing for Dental Surgery. The product is intended for use on moist or bleeding oral wounds to help stabilize blood clots and control bleeding. The recall is due to a process deviation that may have resulted in product lots being released with higher levels of pyrogens than permitted by the product specifications.
The affected products were distributed worldwide, including the United States (nationwide, including 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. Specific lot codes associated with the recall include 1125414, 1126013, 1130645, 1110250, 1110251, 1110252, 1111365, and 1111878.
Healthcare providers and consumers should check their inventory for the specific lot codes listed above. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to the recall instructions.
The recalled product
- Product
- HeliTape 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
- 19,030
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 (5)
- 1125414
- 1126013 1130645
- 1110250 1110251
- 1110252 1111365
- 1111878
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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