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Early Alert: Convenience Kit Needle Issue from Integra LifeSciences
The FDA is aware that Integra LifeSciences has issued a letter to affected customers recommending certain Codman Microsensor Basic Kits and Cerelink ICP Sensor Basic Kits be removed from where they are used or sold.
Integra LifeSciences stated that certain lots of Microsensor and Cerelink ICP Kits were released with potential corrosion stains on the surface of the included 14-gauge Tuohy Needle.
Use of affected product with potential corrosion on the 14-gauge Tuohy Needle (found in the kit) may lead to inflammation, requiring professional medical intervention beyond the standard of care, toxic response, infection, and fever. If the product has already been used, there is no long-term risk to the patient, and no follow-up is required besides standard operative care.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Integra LifeSciences at custsvcnj@integralife.com or 1-800-654-2873.
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