Portex Perfit Percutaneous Tracheostomy Tube Replacement Kit, Sterile Ref: 536090
FDA device recall Z-0100-2008 · posted 2007-11-07 · Terminated
Recall details
- Recalling firm
- Smiths Medical ASD, Inc.
- Reason for recall
- Mislabeled. The product is labeled as a size 9.0 mm tracheostomy tube, but the package contains a 7.0 mm tracheostomy tube.
- Action taken
- Smiths Medical contacted direct customers and US distributors by letter sent by UPS on Septmeber 18, 2007. US Distributors instructed to return their inventory and provide a customer list to Smiths Medical.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JOH
- Quantity affected
- 40 units
- Distribution
- Nationwide.
- Date initiated
- 2007-09-18
- Date posted
- 2007-11-07
- 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 |