FDA Medical Device Recalls (openFDA)
Smiths Medical ASD, Inc.: Portex Per-Fit Percutaneous Dilational Tracheostomy Kit ,ID 7.0mm Product Number: 535070
- Recall number
- Z-0867-05
- Recalling firm
- Smiths Medical ASD, Inc.
- Product
- Portex Per-Fit Percutaneous Dilational Tracheostomy Kit ,ID 7.0mm Product Number: 535070
- Status
- Terminated
- Initiated
- 2005-05-16
- Posted
- 2005-06-04
- Terminated
- 2012-05-08
- Reason
- Guiding catheter may have thinner and weaker sidewalls than designed, and may break.
- Root cause
- Other
- Action
- Smith Medical ASD initiated recall by letter on/about about May 16, 2005.
- Quantity
- not on file
- Distribution
- Natiowide Foreign: Canada, Mexico and East Timor.
- Lot, serial or model codes
- Lot Numbers: K518075, K520177, K548751, K573622, K614995
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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