Recall Z-0817-2022 ยท OJG Neurological Tray
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
| Date | Jan 21, 2022 |
| Status | Terminated |
| 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 Ta |
| Quantity | 1161 kits |
| Distribution | Worldwide distribution - US Nationwide and the country of Hong Kong. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.