—#192068

Product

Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage procedures. Product umber: 826614

FDA product code: OJG — Neurological Tray
Device class: Class 1
Medical specialty: Neurology
Affected lot / code info: Lot Numbers: 20LDC222, 21HDC461 UDI# 10381780520375

Why it was recalled

Incorrect extended expiration dates identified on the outer box label only, if product is used past the correct expiration date there is a potential for pain, infection, or adverse tissue reaction to occur

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Integra issued Urgent: Voluntary Medical Deice Correction letter to Distributors and Hospitals dated 1/21/22 stating reason for recall, health risk and action to take: 1. Please review and understand the information provided in this letter. 2. Please ensure you follow the Instructions for Use and use the product by the expiration dates on the labels within the kit for remaining product on your shelf; these expiration dates are all correct as labeled. 3. Please strike out the incorrect expiration dates on the outer box label of the affected product and write the correct expiration dates per Table 1. 4. Complete the attached Acknowledgement Form (even if you have no product on hand) and return the completed form to FCA3@integralife.com or FAX to 1-609-750-4220 indicating receipt and review of this notification. Keep a copy of the form for your records. We recommend you also maintain a copy of this notification and the signed copy of the acknowledgement form for your records. Regulatory agencies such as the FDA perform audits of field actions of this nature to verify that our customers have been notified and understand the nature of the field action. Should you have any questions regarding these instructions, please contact Customer Service: Monday to Friday 8:00 AM 8:00 PM EST Phone: 1-800-654-2873 Email: custsvcnj@integralife.com

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 1100 Campus Rd, Princeton, New Jersey 08540-6650

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the country of Hong Kong.

Timeline

Recall initiated: 2022-01-21
Terminated: 2024-03-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #192068. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.