CODMAN recallZ-0818-2022 · Integra LifeSciences Corp. · initiated Jan 21, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Integra LifeSciences Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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
FDA root cause category: Under Investigation by firm
What the company is doing
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 [email protected] 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: [email protected]
Recall details
- Recall number
- Z-0818-2022
- Status
- Terminated
- Initiated by the company
- Jan 21, 2022
- Recalling firm
- Integra LifeSciences Corp.
- Quantity
- 1160 kits
- Product code
- OJG
- Distribution
- Worldwide distribution - US Nationwide and the country of Hong Kong.
Product description
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. Part Number: 826616
Code information (models, lots, serial numbers)
Lot Numbers: 20DDA264, 21HDA861 UDI# 10381780520382
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- CODMAN® 826616Integra Lifesciences Production Corporation · Device, monitoring, intracranial pressure1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 89618).
- Z-0817-2022 · TerminatedCodman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage procedures…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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