Recall Z-2138-2024 ยท JXG Shunt, Central Nervous System And Components
Integra LifeSciences Corp.
CODMAN BACTISEAL Clear EVD Catheter 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: 821750
| Date | Jun 12, 2024 (initiated May 7, 2024) |
| Status | Open, Classified |
| Reason | Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility. |
| Root cause | Process control |
| Action | Integra issued 1st Notification- Urgent: Voluntary Medical Device Recall Letter courier service, facsimile or email between May 7th and May 9th, 2024. Letter states reason for recall, health risk and action to take: Actions to be Taken by Customers: 1. If you do have units of the affected product listed in Table 1, remove them immediately from service and quarantine them. 2. If you do have affected product, check the box on the enclosed Acknowledgement Form I do have affected product. Record the total quantity of the affected product that you have. 3. Forward this notice to those who utilize t |
| Quantity | 59 units |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K233448 | Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set Integra Lifesciences Production Corporation, Dec 19, 2023 |