Lo-Profile Fenestrated Tracheostomy Tube, Cuffed and Fenestrated Tube I.D. 9.0mm Catalog Number: 593090
FDA Recall Z-1039-03 · Posted 2003-07-23
Recalling FirmPortex Inc.
Recall StatusTerminated
Product CodeBTO
Date Initiated2003-06-18
Date Terminated2004-03-31
Product Quantity11 units
Reason for Recall
Mislabeled:Tracheostomy tube was not fenestrated as specified on the label
Firm 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.
Root Cause
Other
Distribution Pattern
CA, GA, KA, MO
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.