FDA recall Z-0818-2022

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

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2022-01-21

Report date

2022-03-30

Termination date

2024-03-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0818-2022