FDA Medical Device Recalls (openFDA)
Smiths Medical ASD, Inc.: PER-FIT Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube REF # 511080
- Recall number
- Z-0569-04
- Recalling firm
- Smiths Medical ASD, Inc.
- Product
- PER-FIT Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube REF # 511080
- Status
- Terminated
- Initiated
- 2003-12-12
- Posted
- 2004-07-20
- Terminated
- 2006-05-02
- Reason
- Lid tray incorrectly labeled as Tube I.D. 7.0 mm instead of correct size 8.0 mm
- Root cause
- Other
- Action
- Smiths Medical contacted dealers via telephone on December 12, 2003. The direct customers to whom product was shipped contacted via a visit by the Smiths Medical sales representative Monday, December 15, 2003 through December 12,2 003.
- Quantity
- 30 CASES (2/CASE)
- Distribution
- AZ, CA, CO, CT, FL, GA, IN, MA, NJ, NY, TN, TX, WI
- Lot, serial or model codes
- Lot Number: K223373
- 510(k) numbers
- ["K980466"]
- 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