FDA Medical Device Recalls (openFDA)
Smiths Medical ASD, Inc: Portex Inner Cannula for Tracheostomy Tube, 8.0 mm, REF Code 566080
- Recall number
- Z-1017-04
- Recalling firm
- Smiths Medical ASD, Inc
- Product
- Portex Inner Cannula for Tracheostomy Tube, 8.0 mm, REF Code 566080
- Status
- Terminated
- Initiated
- 2004-05-19
- Posted
- 2004-07-20
- Terminated
- 2006-05-02
- Reason
- Incompatible products may cause potential trachea trauma
- Root cause
- Other
- Action
- Smiths Medical ASD notified the consignees by letter, dated 5/21/04. All responses to the notification are to be completed by fax and directed to Smiths Medical Regulatory Affairs Departement. The recalled products are to be returned and scrapped by Smiths Medical.
- Quantity
- 60,400
- Distribution
- Nationwide
- Lot, serial or model codes
- All Lot Numbers
- 510(k) numbers
- ["K902180"]
- PMA numbers
- not on file
- Product code
- JOH
- Firm FEI
- not on file
- 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