FDA Enforcement
Class II
Ongoing
CODMAN EVD BACTISEAL 1.9mm I.D. 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: 821749
Recall: Z-2137-2024
·
Reported June 19, 2024
Enforcement
- Recall Number
- Z-2137-2024
- Event ID
- 94622
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Integra LifeSciences Corp.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- June 19, 2024
- Initiation Date
- May 7, 2024
- Classification Date
- June 12, 2024
- Address
- 1100 Campus Rd, N/A, Princeton, NJ, 08540-6650, United States
Description
CODMAN EVD BACTISEAL 1.9mm I.D. 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: 821749
Reason
Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.
Code Info
UDI-DI: 10381780518440 Lot numbers: 7314912, 7320010, 7322933
Distribution
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
Quantity
106 units