Integra NeuraWrap Nerve Protector Recalled for Pyrogen Levels
Integra LifeSciences is recalling 954 boxes of NeuraWrap Nerve Protector 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 a risk-of-harm product (pyrogens) where no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Integra LifeSciences Corporation is recalling 954 boxes of NeuraWrap Nerve Protector. The product is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue. 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 product was distributed worldwide, including the United States (nationwide) and Puerto Rico, as well 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. The specific lot codes involved are 1112107, 1111938, 1112280, 1112038, 1111971, 1112279, 1112104, 1112105, and 1112297.
Healthcare providers and patients should stop using the affected lots of NeuraWrap Nerve Protector and contact Integra LifeSciences Corporation for further instructions on the return or replacement of the product.
The recalled product
- Product
- NeuraWrap Nerve Protector NeuraWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.
- Manufacturer
- Integra LifeSciences Corporation
- Category
- Medical Device — Nerve Protector
- Hazard
- Affected units
- 954
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 (6)
- 1112107 1111938
- 1112280
- 1112038
- 1111971 1112279
- 1112104
- 1112105 1112297
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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