FDA Medical Device Recalls (openFDA)
Integra LifeSciences Corp.: 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
- Recall number
- Z-0817-2022
- Recalling firm
- Integra LifeSciences Corp.
- 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
- Status
- Terminated
- Initiated
- 2022-01-21
- Posted
- not on file
- Terminated
- 2024-03-19
- Reason
- 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
- Under Investigation by firm
- Action
- 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
- Quantity
- 1161 kits
- Distribution
- Worldwide distribution - US Nationwide and the country of Hong Kong.
- Lot, serial or model codes
- Lot Numbers: 20LDC222, 21HDC461 UDI# 10381780520375
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OJG
- Firm FEI
- 3003418325
- Firm city
- Princeton
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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