FDA Medical Device Recalls (openFDA)
Smiths Medical ASD, Inc: Portex Tracheal Tube Guide 15 Fr, non-sterile Catalog Number: 153013
- Recall number
- Z-0572-04
- Recalling firm
- Smiths Medical ASD, Inc
- Product
- Portex Tracheal Tube Guide 15 Fr, non-sterile Catalog Number: 153013
- Status
- Terminated
- Initiated
- 2004-01-26
- Posted
- 2004-07-20
- Terminated
- 2012-05-08
- Reason
- Tracheal tube guide mislabeled as a 15 Fr instead of a 10 Fr
- Root cause
- Other
- Action
- Smiths Medical notified consignees by letter dated 1/26/04 by FedEx. Customers are requested to inspect their inventory for the size. Incorrectly labeled product is to be returned for credit or replacement. Customers and dealers are directed to fax back the attached Reply Letter.
- Quantity
- 46 cases (230 UNITS)
- Distribution
- CA, CO, FL, GA, IN, MA, MD, MI. NH, NC, NY, TX, WA
- Lot, serial or model codes
- Lot Number: K221961
- 510(k) numbers
- ["K902180"]
- PMA numbers
- not on file
- Product code
- BSR
- 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