Integra Ora Plug Collagen Wound Dressing Recalled for Pyrogen Levels
Integra LifeSciences is recalling Ora Plug Absorbable Collagen Wound Dressings 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 involves a medical device with a potential contamination (pyrogens) that poses a risk of harm, but the source text does not report any specific illnesses or injuries, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Integra LifeSciences Corporation is recalling 31,940 boxes of Ora Plug 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 was initiated 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. Pyrogens are substances that can cause fever when introduced into the body.
The affected lots are identified by codes 1110144, 1110243, 1110782, and 1111645. The products were distributed worldwide, including the United States (nationwide, including Puerto Rico) and numerous international markets. Healthcare providers and patients should stop using the affected lots and contact the manufacturer or their supplier for further instructions.
The recalled product
- Product
- Ora Plug 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
- 31,940
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)
- 1110144
- 1110243 1110782
- 1111645
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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