Z-2136-2024 Class II Ongoing
FDA device recall Z-2136-2024 was initiated by Integra LifeSciences Corp. on May 7, 2024 and is designated Class II. Reason for recall: Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal that may compromise the product sterility. The recall status is ongoing. Affected quantity: 135 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 19, 2024
- Initiation Date
- May 7, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 135 units
Product Description
CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume. Product Number: 821745
Reason for Recall
Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal that may compromise the product sterility.
Distribution Pattern
Worldwide - US Nationwide distribution in the state of TX and the countries of Canada, China, Croatia, Hungary, Russia, Singapore, Slovenia, South Africa, Taiwan (Province of China), Turkey
Code Information
UDI-DI: 10381780515593 Lot numbers: 7320001, 7320004, 720005, 7322926, 322927
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2136-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026