Recall Z-0725-2021 ยท JXG Shunt, Central Nervous System And Components
Integra LifeSciences Corp.
Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed for use in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. Part Number: 823087
| Date | Dec 14, 2020 |
| Status | Terminated |
| Reason | Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087) and vs. versa |
| Root cause | Labeling Change Control |
| Action | Integra Lifesciences notified consignees (Hospitals and Sales Representatives ) by Urgent Medical Device Recall letter between December 14 and 16, 2020 via courier service, facsimile or email about the initial notification between December 14 and 16, 2020. Letter state reason for recall, health risk and action to take: Customers a. If you do have the affected product in Table 1, remove the product from service. b. Complete the attached acknowledgement form. If you do have affected product, check the box I do have affected product. Record the total quantity of the affected product you have. c. |
| Quantity | 17 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110751 | CODMAN BACTISEAL ENDOSCOPIC VENTICULAR CATHETER Codman & Shurtleff, Inc., May 9, 2011 |