Z-0818-2022Class II

Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure...

Name: Z-0818-2022 Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure...
Creator: Integra LifeSciences Corp.
Published: 2022-01-21
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2022-01-21 / Terminated / root cause: labeling and UDI

FDA source

Integra LifeSciences Corp. began a recall of Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal... on 2022-01-21. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0818-2022
Classification: Class II
Status: Terminated
Initiated: 2022-01-21
Posted: 2022-03-22
Terminated: 2024-03-19
Recalling firm: Integra LifeSciences Corporation
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. Part Number: 826616
Product code: OJG Neurological Tray
Reason for recall: 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 tag: labeling and UDI
FDA 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 [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]
Quantity in commerce: 1160 kits
Distribution: Worldwide distribution - US Nationwide and the country of Hong Kong.
Product codes and lots: Lot Numbers: 20DDA264, 21HDA861 UDI# 10381780520382

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0818-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0817-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-30	2022-03-22
Z-0818-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-30	2022-03-22

Product code OJG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)