HeliPlug Collagen Wound Dressing Recalled for Pyrogen Levels
Integra LifeSciences is recalling HeliPlug Absorbable Collagen Wound Dressings for dental surgery because process deviations may have resulted in higher pyrogen levels than permitted.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a potential deviation from specifications (pyrogens) without confirmed adverse health consequences, fitting the criteria for a moderate severity score.
Plain-English summary
Integra LifeSciences Corporation is recalling HeliPlug Absorbable Collagen Wound Dressings for Dental Surgery. The product is intended for use on moist or bleeding oral wounds to help protect the surface and control bleeding. The recall involves 42,570 boxes distributed worldwide, including the United States, Puerto Rico, and various international markets.
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. Pyrogens are substances that can cause fever or other adverse reactions when introduced into the body.
The affected lots are identified by the following codes: 1104622, 1104962, 1110241, 1110242, 1110264, and 1110783. Healthcare providers and patients should check their inventory or records for these specific lot numbers. If you have used or possess these products, contact your healthcare provider or the manufacturer for further instructions on proper disposal or replacement.
The recalled product
- Product
- HeliPlug 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 Care
- Affected units
- 42,570
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 (4)
- 1104622
- 1104962 1110241
- 1110242 1110264
- 1110783
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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