FDA Medical Device Recalls (openFDA)
Portex Inc.: Lo-Profile Fenestrated Tracheostomy Tube, Cuffed and Fenestrated Tube I.D. 9.0mm Catalog Number: 593090
- Recall number
- Z-1039-03
- Recalling firm
- Portex Inc.
- Product
- Lo-Profile Fenestrated Tracheostomy Tube, Cuffed and Fenestrated Tube I.D. 9.0mm Catalog Number: 593090
- Status
- Terminated
- Initiated
- 2003-06-18
- Posted
- 2003-07-23
- Terminated
- 2004-03-31
- 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
- Lot, serial or model codes
- Lot Number: 905486 EXP: 2004-05
- 510(k) numbers
- ["K922749"]
- PMA numbers
- not on file
- Product code
- BTO
- Firm FEI
- 1217052
- Firm city
- Keene
- Firm state
- NH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28