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Recall Observatory FDA recall evidence

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. Product umber: 826614

Z-0817-2022

January 21, 2022

Class II

Product summary

Firm
Integra LifeSciences Corp.
Event
Event 89618
Status
Terminated
Classification
Class II
Quantity
1161 kits
Official record key
device-enforcement:Z-0817-2022

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: 20LDC222, 21HDC461 UDI# 10381780520375

Distribution pattern: Worldwide distribution - US Nationwide and the country of Hong Kong.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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