Recall Z-1039-03 ยท BTO Tube, Tracheostomy (W/Wo Connector)
Portex Inc.
Lo-Profile Fenestrated Tracheostomy Tube, Cuffed and Fenestrated Tube I.D. 9.0mm Catalog Number: 593090
| Date | Jul 23, 2003 (initiated Jun 18, 2003) |
| Status | Terminated |
| Reason | Mislabeled:Tracheostomy tube was not fenestrated as specified on the label |
| Root cause | Other |
| Action | Portex notified four user facilities by telephone on June 18th and 19th, 2003 . The consignees were instructed to check their inventory for any affected product and to call to make arrangements for the return and credit of the affected product. If the product was in use, they were instructed to remove the fenestrated label on the inflation line and to inform the patient and healthcare provider of the discrepancy. |
| Quantity | 11 units |
| Distribution | CA, GA, KA, MO |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K922749 | LOW PROFILE TRACHEOSTOMY TUBE Concord/Portex, Sep 2, 1992 |