Integra OraTape Collagen Wound Dressing Recalled for Pyrogen Levels
Integra LifeSciences is recalling OraTape Absorbable Collagen Wound Dressings 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. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.
Plain-English summary
Integra LifeSciences Corporation is recalling 17,110 boxes of OraTape Absorbable Collagen Wound Dressing for Dental Surgery. The recall was initiated 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 is intended for use on moist or bleeding oral wounds to help stabilize blood clots and protect the wound surface. The distribution was worldwide, including the United States (nationwide, including Puerto Rico) and numerous international countries such as Canada, China, Japan, and various European and South American nations.
Consumers and healthcare providers should stop using the affected product and contact the manufacturer or their supplier for instructions on return or replacement. The specific lot codes involved in this recall are 1126012, 1105396, 1105397, 1105398, 1105399, 1111364, and 1111641.
The recalled product
- Product
- OraTape 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 a
- Manufacturer
- Integra LifeSciences Corporation
- Category
- Medical Device — Wound Dressing
- Hazard
- Affected units
- 17,110
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)
- 1126012
- 1105396 1105397
- 1105398 1105399
- 1111364 1111641
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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