Integra Cranial Access Kit Recalled for Sterile Packaging Defect
Integra LifeSciences is recalling 27 units of its Cranial Access Kit due to defective sterile packaging that may compromise product sterility. The kits 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 an FDA Class II medical device recall involving a defect in sterile packaging that potentially compromises product sterility on a neurosurgical device. No illnesses or injuries have been reported. The hazard is serious due to the risk-of-harm nature of the application, but remains theoretical pending clinical outcomes.
Plain-English summary
Integra LifeSciences Corp. is recalling 27 units of the Integra Cranial Access Kit (Ref No: HITHSP04), a medical device used in neurosurgery to access the subarachnoid space and lateral ventricles of the brain.
The sterile packaging (header bag) for these units failed required packaging integrity testing criteria. This defect potentially compromises the sterility of the product, creating a risk of infection if used in surgical procedures.
The affected units were distributed worldwide, including throughout the United States and 18 other countries: Austria, Bahamas, Belgium, Canada, Chile, France, Germany, Greece, Ireland, Israel, Poland, Portugal, Slovenia, South Africa, Spain, United Arab Emirates, and the United Kingdom. The affected lot number is 7257028, with an expiration date of June 1, 2024.
Healthcare facilities that received these units should immediately discontinue use and contact Integra LifeSciences Corp. for device return or disposal instructions. Facilities should verify their inventory by checking for lot number 7257028 to identify affected units.
The recalled product
- Product
- Ref No: HITHSP04 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
- Manufacturer
- Integra LifeSciences Corp.
- Affected units
- 27
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: 10381780263869 Lot Number: 7257028 Exp. Date: 1-Jun-24
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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