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
Reported: March 30, 2022 Initiated: January 21, 2022 #Z-0818-2022
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
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
Details
- Recalling Firm
- Integra LifeSciences Corp.
- Units Affected
- 1160 kits
- Distribution
- Worldwide distribution - US Nationwide and the country of Hong Kong.
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Integra LifeSciences Corp.. Units affected: 1160 kits.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 30, 2022. Severity: Moderate. Recall number: Z-0818-2022.
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