Integra LifeSciences Corp. Recall 89618
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
Integra LifeSciences Corp. Recall 89618 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0818-2022 |
| Event ID | 89618 |
| Event 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 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the country of Hong Kong. |
| Quantity | 1160 kits |
| Recall 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 |
| Device Classification | 20220330 |
| Device Code Info | Lot Numbers: 20DDA264, 21HDA861 UDI# 10381780520382 |
| Center Classification Date | 20220322 |
| Recall Initiation Date | 20220121 |
| Recalling Firm | Integra LifeSciences Corp. |
| Initial Notification | Letter |
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