Tandem-Cath Hemodialysis Cuffed Catheter with no side holes 10 Fr 23 cm Arterial Cuff/26cm Venous Cuff Code #: 8888-2232
FDA device recall Z-0746-03 · posted 2003-04-18 · Terminated
Recall details
- Recalling firm
- Tyco Healthcare/Kendall
- Reason for recall
- Tandem Hemodialysis Catheter may have splits in the catheter shaft below the extension adapter
- Action taken
- The firm notified accounts by letter on 3/20/03 by overnight mail delivery. Users are requested to examine, remove and return product.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 167
- Distribution
- Nationwide International: Canada, Chile, Singapore. Belgium
- Date initiated
- 2003-03-20
- Date posted
- 2003-04-18
- Date terminated
- 2021-05-12
- Location
- Mansfield, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS (K002902) | The Kendall Company | 2001-04-09 |