Z-1873-2024Class II

Integra Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure...

Name: Z-1873-2024 Integra Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure...
Creator: Integra LifeSciences Corp.
Published: 2024-04-17
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2024-04-17 / Open, Classified / root cause: manufacturing process

FDA source

Integra LifeSciences Corp. began a recall of Integra Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND on 2024-04-17. FDA classified it as Class II and gives the reason as "Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1873-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-17
Posted: 2024-05-20
Recalling firm: Integra LifeSciences Corporation
Product: Integra Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND
Product code: HBG Drills, Burrs, Trephines & Accessories (Manual)
Reason for recall: Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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]
Quantity in commerce: 1,822 units
Distribution: Worldwide distribution - US Nationwide and the countries of CA, BE, CL.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1873-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1873-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-29	2024-05-20

Product code HBG

K961113Class IICns Interchangeable Bit Cranial DrillClinical Neuro Systems, LLC / cleared 1996-06-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)