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U.S. Department of Health and Human Services

Class 2 Device Recall Integra Codman Cranial Access Kits

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  Class 2 Device Recall Integra Codman Cranial Access Kits see related information
Date Initiated by Firm January 21, 2022
Create Date March 22, 2022
Recall Status1 Terminated 3 on March 19, 2024
Recall Number Z-0818-2022
Recall Event ID 89618
Product Classification Neurological tray - Product Code OJG
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
Code Information Lot Numbers: 20DDA264, 21HDA861 UDI# 10381780520382
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
1100 Campus Rd
Princeton NJ 08540-6650
For Additional Information Contact Lacey Gigante
609-212-9004
Manufacturer 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
FDA Determined
Cause 2		 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 in Commerce 1160 kits
Distribution Worldwide distribution - US Nationwide and the country of Hong Kong.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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