Integra Cranial access kit (without Prep solutions) Bit and… recallZ-1873-2024 · Integra LifeSciences Corp. · initiated Apr 17, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Integra LifeSciences Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.
FDA root cause category: Process control
What the company is doing
Integra LifeSciences issued First Notification: Urgent: Voluntary Medical Device Recall Letter delivered by courier service, facsimile or email between April 17th and April 18th, 2024. Letter states reason for recall, health risk and action to take: 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. If you do not have affected product, check the box, I do not have affected product. 5. After completion, please email the Acknowledgement Form to [email protected] or FAX to 1-609-750- 4220. 6. Keep a copy of the form for your records. 7. Please check your customer traceability records for shipments of above catalog and lot numbers. 8. Forward a copy of the enclosed Field Safety Notice to any of your customers that have purchased the above catalog and lot number. 9. 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 contact you or your customer and provide an RMA number and directions to return the product. You can request a credit for the quantities returned. Receipt of this form ensures that Integra has achieved a level of effectiveness in communicating this information. We recommend you also maintain a copy of this notification and the signed copy of the acknowledgement form for your records. Should you have any questions regarding these instructions, please contact Customer Service: Monday to Friday 8:00 AM 8:00 PM EST USA: 1-800-654-2873: email: [email protected]
Recall details
- Recall number
- Z-1873-2024
- Status
- Open, Classified
- Initiated by the company
- Apr 17, 2024
- Posted by the FDA
- May 20, 2024
- Recalling firm
- Integra LifeSciences Corp.
- Quantity
- 1,822 units
- Product code
- HBG
- FDA submissions
- K961113
- Distribution
- Worldwide distribution - US Nationwide and the countries of CA, BE, CL.
Product description
Integra Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND
Code information (models, lots, serial numbers)
UDI-DI: 10381780263906 Lot Number/Exp. Date: 7257032 07/16/2025 ; 7275713 09/03/2025 ; 7291974 09/03/2025; 7312131 09/03/2025; 7289690 09/03/2025; 7291975 09/03/2025; 7312137 09/03/2025 7312139 09/03/2025
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Integra® INS5HNDIntegra Pain Management3 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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