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

FDA device recall Z-1873-2024 · posted 2024-05-20 · Open, Classified

Recall details

Recalling firm

Integra LifeSciences Corp.

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.

Action taken

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 FCA3@integralife.com 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: custsvcnj@integralife.com

Root cause

Process control

Status

Open, Classified

Product code

HBG

Quantity affected

1,822 units

Distribution

Worldwide distribution - US Nationwide and the countries of CA, BE, CL.

Date initiated

2024-04-17

Date posted

2024-05-20

Location

Princeton, NJ

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