Portex Per-Fit Percutaneous Dilational Tracheostomy Kit , ID 9.0mm Product Number: 535090
FDA device recall Z-0869-05 · posted 2005-06-04 · Terminated
Recall details
- Recalling firm
- Smiths Medical ASD, Inc.
- Reason for recall
- Guiding catheter may have thinner and weaker sidewalls than designed, and may break.
- Action taken
- Smith Medical ASD initiated recall by letter on/about about May 16, 2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- JOH
- Distribution
- Natiowide Foreign: Canada, Mexico and East Timor.
- Date initiated
- 2005-05-16
- Date posted
- 2005-06-04
- Date terminated
- 2012-05-08
- Location
- Keene, NH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT (K031057) | Portex, Inc. | 2003-07-18 |