Integra Absorbable Collagen Sponge Recalled for Pyrogen Levels
Integra LifeSciences is recalling absorbable collagen sponges due to a process deviation that may have resulted in higher pyrogen levels 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 risk of harm (pyrogens) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
Integra LifeSciences Corporation is recalling 84,460 boxes of Absorbable Collagen Sponge. The product was provided as an intermediate to another company. The recall is 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 products were distributed worldwide, including the United States (nationwide) and Puerto Rico, as well as 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 are listed in the official recall documentation.
Consumers and healthcare providers should stop using the affected products and contact the manufacturer or their supplier for instructions on return or replacement. No specific illnesses or injuries are reported in the source text.
The recalled product
- Product
- Absorbable Collagen Sponge Provided As Intermediate to Another Company
- Manufacturer
- Integra LifeSciences Corporation
- Category
- Medical Device — Surgical Sponge
- Hazard
- Affected units
- 84,460
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 (20)
- 1130055
- 1130057
- 1130228
- 1130229
- 1130388
- 1105192
- 1110821
- 1110822
- 1110987
- 1111023
- 1112020
- 1112379
- 1104815
- 1110841
- 1110842
- 1110843
- 1110953
- 1110954
- 1111022
- 1111821
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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