Recall Z-2397-2008 ยท MSD Catheter, Hemodialysis, Implanted
Angiodynamics, Inc.
Centros(TM) 15F x 28cm Chronic Hemodialysis Curved Catheter Set (With Cuff 23cm From Tip), Catalog No./REF 10303102. Sterile. Manufactured for AngioDynamics, Inc. MANUFACTURED IN USA. ANGIODYNAMICS, INC. Queensbury, NY USA 12804.
| Date | Sep 24, 2008 (initiated Jul 7, 2008) |
| Status | Terminated |
| Reason | The cuff may be inadequately attached to the catheter, resulting in possible catheter movement or leakage at the insertion site. |
| Root cause | Process design |
| Action | AngioDynamics sent URGENT MEDICAL DEVICE letters and reply forms to the consignees via Certified Mail on/about 7/10/08. The recall is being conducted to the medical user level. AngioDynamics is requesting the return of all Centros Hemodialysis Catheters in inventory. The following steps should be taken by the consignees: 1. Identify and segregate the recalled product that is in your possession. 2. Complete the enclosed Centros Hemodialysis Catheter Recall Reply Form and fax it to the attention of the Centros Recall Coordinator at 518-798-1360. It is important that even if you do not have |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070572 | ASH ADVANCE HEMODIALYSIS CATHETER AND PROCEDURE KIT, MODELS; 15FR X 24CM, 15FR X 28CM, 15FR X 32CM Ash Access Technology, Inc., Jun 26, 2007 |