Integra Cranial Access Kit Recalled for Defective Sterile Packaging
Integra LifeSciences is recalling 915 units of its Cranial Access Kit worldwide due to defective sterile packaging that may compromise product sterility. The header bags failed required packaging integrity testing.
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: This is a Class II FDA recall for compromised sterile packaging on a surgical device. No illnesses or injuries have been reported. The hazard is theoretical (potential sterility compromise) rather than documented harm, placing this at score 3 per the rubric for risk-of-harm products without reported injury.
Plain-English summary
Integra LifeSciences Corp. is recalling the Integra Cranial Access Kit (Reference No. INSHITHND), a surgical instrument designed for accessing the subarachnoid space or lateral ventricles of the brain during neurosurgical procedures. The recall affects 915 units worldwide.
The recall was initiated due to a defect in the sterile packaging (header bag) of the kit. The header bags failed required packaging integrity testing criteria, which means the sterility of the product may be compromised. Compromised sterility in a surgical instrument poses a potential infection risk to patients undergoing neurosurgical procedures.
The affected units were distributed worldwide, including throughout the United States and to Austria, Bahamas, Belgium, Canada, Chile, France, Germany, Greece, Ireland, Israel, Poland, Portugal, Slovenia, South Africa, Spain, and the United Arab Emirates. Affected lot numbers and expiration dates are available from the FDA.
Healthcare providers should immediately stop using the recalled units and contact Integra LifeSciences for return instructions. Patients who have undergone procedures using the affected product should consult with their healthcare provider about any potential concerns.
The recalled product
- Product
- Ref No: INSHITHND / Integra¿ Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles of the brain.
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- packaging-defect
- compromised-sterility
Distribution
Distributed nationwide across the United States.
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