FDA-Device2022-03-30Class II
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.
Hazard
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
Sold states
Worldwide distribution - US Nationwide and the country of Hong Kong.
Affected count
1160 kits
Manufactured in
1100 Campus Rd, N/A, Princeton, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0818-2022Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief