Recall Z-0100-2008 ยท JOH Tube Tracheostomy And Tube Cuff
Smiths Medical ASD, Inc.
Portex Perfit Percutaneous Tracheostomy Tube Replacement Kit, Sterile Ref: 536090
| Date | Nov 7, 2007 (initiated Sep 18, 2007) |
| Status | Terminated |
| Reason | Mislabeled. The product is labeled as a size 9.0 mm tracheostomy tube, but the package contains a 7.0 mm tracheostomy tube. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 40 units |
| Distribution | Nationwide. |
| 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 |