Integra Cranial Access Kit Recalled for Compromised Sterile Packaging
Integra LifeSciences is recalling 8,906 units of the Cranial Access Kit because the sterile packaging failed integrity testing, potentially compromising sterility. Units were distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 risk-of-harm product (a surgical device where sterility is critical to safety) with potentially compromised sterility due to packaging defect. However, no illnesses or injuries have been reported, and the sterility compromise is theoretical. FDA classified this as Class II, not Class I.
Plain-English summary
Integra LifeSciences Corp. is recalling the Integra Cranial Access Kit, a medical device used to access the subarachnoid space or lateral ventricles of the brain during neurosurgery. The recall affects 8,906 units distributed in the United States and internationally, including Austria, Bahamas, Belgium, Canada, Chile, France, Germany, Greece, Ireland, Israel, Poland, Portugal, Slovenia, South Africa, Spain, and the United Arab Emirates.
The recall was issued because of a defect in the sterile packaging (header bag) of the Cranial Access Kit. The packaging failed required integrity testing criteria, which means the sterility of the affected products may be compromised.
The recall affects units with specific lot numbers and expiration dates ranging from September 2023 through June 2024. Healthcare facilities, surgeons, and distributors with affected units should stop using these products immediately and contact Integra LifeSciences Corp. for instructions on return, replacement, or disposition of affected inventory.
The recalled product
- Product
- Ref No: INSHITH / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
- Manufacturer
- Integra LifeSciences Corp.
- Affected units
- 8,906
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by Integra LifeSciences Corp. 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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