The Recall Desk
HighFDA (Devices)·Z-1291-2013·Announced 2013-05-22

Integra Recalls Collagen Wound Dressings Due to Pyrogen Levels

Integra LifeSciences is recalling 49,500 boxes of Colla Tape 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 involves a medical device with a process deviation leading to higher pyrogen levels, which poses a risk of harm (fever/inflammation) even though no specific injuries are reported in the source text.

Plain-English summary

Integra LifeSciences Corporation is recalling 49,500 boxes of Colla Tape Absorbable Collagen Wound Dressings 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 caused the affected product lots to be released with higher levels of pyrogens than permitted by the product specifications.

The affected products were distributed worldwide, including the United States (nationwide) and Puerto Rico, as well as countries such as the Arab Emirates, Argentina, Belgium, Brazil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa. Specific lot codes are listed in the agency's recall record.

Healthcare providers and consumers should stop using the affected lots of Colla Tape Absorbable Collagen Wound Dressings and contact Integra LifeSciences Corporation for instructions on returning the product.

The recalled product

Product
Colla Tape 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. Topica
Manufacturer
Integra LifeSciences Corporation
Category
Medical Device — Wound Dressing
Hazard
Affected units
49,500

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 (10)

  • 1125130
  • 1125686 1125687
  • 1125688 1126015
  • 1105298 1110145
  • 1110674 1111854
  • 1104502 1104503
  • 1105309 1105310
  • 1110249 1111366
  • 1111367 1111368
  • 1111370 1112262

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 21 products in this recall →

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Same hazard · pyrogens

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