Lo-Profile Fenestrated Tracheostomy Tube, Cuffed and Fenestrated Tube I.D. 9.0mm Catalog Number: 593090
FDA device recall Z-1039-03 · posted 2003-07-23 · Terminated
Recall details
- Recalling firm
- Portex Inc.
- Reason for recall
- Mislabeled:Tracheostomy tube was not fenestrated as specified on the label
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- BTO
- Quantity affected
- 11 units
- Distribution
- CA, GA, KA, MO
- Date initiated
- 2003-06-18
- Date posted
- 2003-07-23
- Date terminated
- 2004-03-31
- 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 |
|---|---|---|
| LOW PROFILE TRACHEOSTOMY TUBE (K922749) | Concord/Portex | 1992-09-02 |