Integra LifeSciences Corp.: Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS5HND

Recall number

Z-0491-2024

Recalling firm

Integra LifeSciences Corp.

Product

Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS5HND

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

1639 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:10381780263906 Lot Number/Exp. Date : 6710219 30-May-25 6788611 30-Oct-25 6788610 30-Oct-25 6896403 30-Oct-25 7248999 17-Jul-25 7073042 20-Jul-25 7249000 29-Jun-25 6710219 30-May-25 6788611 30-Oct-25 6788610 30-Oct-25 6896403 30-Oct-25 7248999 17-Jul-25 7073042 20-Jul-25 7249000 29-Jun-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

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

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