Tyco Healthcare/Kendall
Tandem-Cath Hemodialysis Cuffed Catheter with no side holes 10 Fr 28 cm Arterial Cuff/31cm Venous Cuff Code #: 8888-228310
| Date | Apr 18, 2003 (initiated Mar 20, 2003) |
| Status | Terminated |
| Reason | Tandem Hemodialysis Catheter may have splits in the catheter shaft below the extension adapter |
| Root cause | Other |
| Action | The firm notified accounts by letter on 3/20/03 by overnight mail delivery. Users are requested to examine, remove and return product. |
| Quantity | 164 |
| Distribution | Nationwide International: Canada, Chile, Singapore. Belgium |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002902 | TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS The Kendall Company, Apr 9, 2001 |