Codman Cranial Access Kits- indicated when a craniotomy recall
Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or…
Why was Codman Cranial Access Kits- indicated when a craniotomy recalled?
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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: 20LDC222, 21HDC461 UDI# 10381780520375
- Product
- Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or…
- Recalling firm
- Integra LifeSciences Corp.
- Quantity
- 1161 kits
- Distribution
- Worldwide distribution - US Nationwide and the country of Hong Kong.
- Recall date
- March 30, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)