Recall Z-1354-2021 ยท HCA Catheter, Ventricular
Integra LifeSciences Corp.
CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with drainage Holes and Marking. For use in the treatment of hydrocephalus. Catalog Number: NS5524
| Date | Apr 5, 2021 (initiated Mar 17, 2021) |
| Status | Terminated |
| Reason | Incorrect labeling, Catheter did not have the required holes and markings |
| Root cause | Labeling Change Control |
| Action | Integra LifeSciences issued Voluntary Urgent Medical Device Recall letter via courier service, facsimile or email on March 17th for delivery on March 19th, 2021. Letter states reason for recall, health risk and action to take: 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. If you do not have affected product, check the box, I do not have affected product. d. Return the compl |
| Quantity | 49 units |
| Distribution | CA CO FL KY MD NC NC NY NY TX WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031123 | CODMAN BACTISEAL BARIUM STRIPED CATHETERS Codman & Shurtleff, Inc., May 14, 2003 |