Integra Cranial Access Kit recalls due to packaging sterility defect
Integra LifeSciences is recalling 161 units of the Cranial Access Kit (Lot 7124720) due to packaging defects that may compromise sterility. The recall affects units distributed worldwide.
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: FDA Class II recall for a neurosurgical device with a packaging defect affecting sterility—a critical property for invasive brain procedures. No illnesses or injuries have been reported. Per the rubric, this is a risk-of-harm product where injury has not yet been reported, warranting a High severity rating.
Plain-English summary
The affected product is the Integra Cranial Access Kit (Model INS7260), a sterile medical device used for access to the subarachnoid space or lateral ventricles of the brain. A total of 161 units with Lot Number 7124720 (expiration date September 1, 2024) have been recalled.
The recall was initiated due to a defect in the sterile packaging (header bag) of the kit. The packaging failed required packaging integrity testing criteria, which means the product's sterility may have been compromised.
The affected product was distributed worldwide, including the United States and the following countries: Austria, Bahamas, Belgium, Canada, Chile, France, Germany, Greece, Ireland, Israel, Poland, Portugal, Slovenia, South Africa, Spain, the United Arab Emirates, and the United Kingdom.
Healthcare facilities and clinicians who have received this product should stop use immediately and contact Integra LifeSciences Corp. for instructions on returning or disposing of the recalled units. Patients who have received treatment with this device should consult with their healthcare providers.
The recalled product
- Product
- Ref No: INS7260 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- sterile-packaging-defect
- sterility-compromise
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 (1)
- UDI:10381780431923 Lot Number: 7124720 Exp Date: 1-Sep-24
Distribution
Distributed nationwide across the United States.
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