CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain
FDA device recall Z-2138-2024 · posted 2024-06-12 · Open, Classified
Recall details
- Recalling firm
- Integra LifeSciences Corp.
- Reason for recall
- Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.
- Action taken
- 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 the device so they are aware of this recall and can identify any affected devices that may remain in clinical areas. 4. If you do not have affected product, check the box, I do not have affected product. 5. Complete the rest of the Acknowledgement Form and return to FCA3@integralife.com or FAX to 1-609-750-4220. 6. Keep a copy of the form for your records. 7. When your form is received, and it is noted that you have affected product, Customer Service will contact you and provide a Return Material Authorization (RMA) number and directions to return the affected product. You can request a credit for the quantities returned. Should you have any questions regarding these instructions, please contact Customer Service: Monday to Friday 8:00 AM 8:00 PM EST USA: 1-800-654-2873: email: custsvcnj@integralife.com
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- JXG
- Quantity affected
- 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
- Date initiated
- 2024-05-07
- Date posted
- 2024-06-12
- Location
- Princeton, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set (K233448) | Integra Lifesciences Production Corporation | 2023-12-19 |