FDA Medical Device Recalls (openFDA)
Integra LifeSciences Corp.: Integra Cranial Access Kit- For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7250
- Recall number
- Z-0496-2024
- Recalling firm
- Integra LifeSciences Corp.
- Product
- Integra Cranial Access Kit- For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7250
- Status
- Open, Classified
- Initiated
- 2023-10-19
- Posted
- 2023-12-06
- Terminated
- not on file
- Reason
- Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
- Root cause
- Process control
- Action
- Integra notified consignees (Hospitals, Government facilities, and Distributors) via Fedex priority overnight on 10/19/23 . Letter titled: 1st Notification- Urgent: Voluntary Medical Device Recall. Letter states reason for recall, health risk and action to take: Actions to be Taken by Customers: 1. If you do have units of the affected product listed in Table 1, remove it immediately from service. 2. If you do have affected product, check the box on the enclosed form I do have affected product. Record the total quantity of the affected product that you have. 3. If you do not have affected product, check the box, I do not have affected product. 4. Complete the attached Acknowledgement Form and return to FCA2@integralife.com or FAX to 1-609-750-4220. 5. Keep a copy of the form for your records. 6. When your form is received, and it is noted that you have affected product, Customer Service will contact you and provide a Return Material Authorization (RMA) number and directions to return the affected product. You can request a credit or a replacement for the quantities returned (based on inventory availability). Actions to be Taken by Distributors/Sales Reps: 1. If you do have the affected product listed in Table 1, remove the product from further distribution. 2. Complete the attached acknowledgment form. 3. If you do have affected product, check the box I do have affected product . Record the total quantity of affected product you have. 4. After completion, please email the Acknowledgement Form to FCA2@integralife.com or FAX to 1-609-750-4220. 5. Keep a copy of the form for your records. 6. Please check your customer traceability records for shipments of above catalog and lot numbers. 7. Forward a copy of the enclosed Field Safety Notice to any of your customers that have purchased the above catalog and lot number. 8. When the form from you and your customer is received, and it is noted that you or your customer has affected product, Customer Service will c
- Quantity
- 485 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Canada, Chile, France, Ireland, Israel, South Africa, United Kingdom.
- Lot, serial or model codes
- UDI-DI: 10381780431916 Lot Number/Exp. Date: 6500469 1-Mar-25 6844175 1-Mar-25 7078238 1-May-25
- 510(k) numbers
- ["K961113"]
- PMA numbers
- not on file
- Product code
- HBG
- Firm FEI
- 3003418325
- Firm city
- Princeton
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28