Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) moni
Summary
The FDA issued a Class II for Codman Cranial Access Kits- indicated when a craniotomy is required for placemen by Integra LifeSciences Corp.. 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 f.
Details
Source
Device Recall
External ID
Z-0818-2022
Action Date
2022-03-30
Status
Terminated
Category
device
Product 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
Lot/Code Info: Lot Numbers: 20DDA264, 21HDA861 UDI# 10381780520382
Quantity Affected: 1160 kits
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-21
Company
Princeton, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 146 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Integra LifeSciences Corp. has 64 FDA actions in our database, including 64 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Integra LifeSciences Corp.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Integra LifeSciences Corp. have FDA actions?
Integra LifeSciences Corp. has 64 FDA actions in our database, including 64 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0818-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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