Portex Inc. Lo-Profile Fenestrated Tracheostomy Tube, Cuffed and Fenestrated Tube I.D. 9.0mm Catalog Number: 593090 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Lo-Profile Fenestrated Tracheostomy Tube, Cuffed and Fenestrated Tube I.D. 9.0mm Catalog Number: 593090
Brand
Portex Inc.
Lot Codes / Batch Numbers
Lot Number: 905486 EXP: 2004-05
Products Sold
Lot Number: 905486 EXP: 2004-05
Portex Inc. is recalling Lo-Profile Fenestrated Tracheostomy Tube, Cuffed and Fenestrated Tube I.D. 9.0mm Catalog Number: 593 due to Mislabeled:Tracheostomy tube was not fenestrated as specified on the label. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Mislabeled:Tracheostomy tube was not fenestrated as specified on the label
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, GA, MO
Page updated: Jan 10, 2026