FDAFDA · Food and drugs·Recall number Z-1286-2013
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.
Published May 22, 2013 · Recall initiated: March 28, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Integra LifeSciences Corporation
- Distributor
- Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.
- Lot
- 1112107 1111938, 1112280, 1112038, 1111971 1112279, 1112104, 1112105 1112297,
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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