Device 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
Z-0818-2022
Product summary
- Event
- Event 89618
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1160 kits
- Official record key
device-enforcement:Z-0818-2022
Official wording
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
Code information: Lot Numbers: 20DDA264, 21HDA861 UDI# 10381780520382
Distribution pattern: Worldwide distribution - US Nationwide and the country of Hong Kong.
Derived failure modes
-
Unknown
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