Z-0818-2022 Class II Terminated
FDA device recall Z-0818-2022 was initiated by Integra LifeSciences Corp. on Jan 21, 2022 and is designated Class II. 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… The recall status is terminated (terminated Mar 19, 2024). Affected quantity: 1160 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 30, 2022
- Initiation Date
- Jan 21, 2022
- Termination Date
- Mar 19, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1160 kits
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
Distribution Pattern
Worldwide distribution - US Nationwide and the country of Hong Kong.
Code Information
Lot Numbers: 20DDA264, 21HDA861 UDI# 10381780520382
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0818-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026