FDA Medical Device Recalls (openFDA)
Smiths Medical ASD, Inc.: Portex Perfit Percutaneous Tracheostomy Tube Replacement Kit, Sterile Ref: 536090
- Recall number
- Z-0100-2008
- Recalling firm
- Smiths Medical ASD, Inc.
- Product
- Portex Perfit Percutaneous Tracheostomy Tube Replacement Kit, Sterile Ref: 536090
- Status
- Terminated
- Initiated
- 2007-09-18
- Posted
- 2007-11-07
- Terminated
- 2012-05-08
- Reason
- Mislabeled. The product is labeled as a size 9.0 mm tracheostomy tube, but the package contains a 7.0 mm tracheostomy tube.
- Root cause
- Process control
- Action
- Smiths Medical contacted direct customers and US distributors by letter sent by UPS on Septmeber 18, 2007. US Distributors instructed to return their inventory and provide a customer list to Smiths Medical.
- Quantity
- 40 units
- Distribution
- Nationwide.
- Lot, serial or model codes
- Lot Number: 1155185
- 510(k) numbers
- ["K031057"]
- PMA numbers
- not on file
- Product code
- JOH
- 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