Recall Z-0871-05 ยท JOH Tube Tracheostomy And Tube Cuff
Smiths Medical ASD, Inc.
Portex Per-Fit Percutaneous Dilational Tracheostomy Kit , ID 8.0mm Product Number: 538080E
| Date | Jun 4, 2005 (initiated May 16, 2005) |
| Status | Terminated |
| Reason | Guiding catheter may have thinner and weaker sidewalls than designed, and may break. |
| Root cause | Other |
| Action | Smith Medical ASD initiated recall by letter on/about about May 16, 2005. |
| Distribution | Natiowide Foreign: Canada, Mexico and East Timor. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031057 | PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT Portex, Inc., Jul 18, 2003 |