Recalls / —
—#31341
Product
Portex Tracheal Tube Guide 15 Fr, non-sterile Catalog Number: 153013
- FDA product code
- BSR — Stylet, Tracheal Tube
- Device class
- Class 1
- Medical specialty
- Anesthesiology
- 510(k) numbers
- K902180
- Affected lot / code info
- Lot Number: K221961
Why it was recalled
Tracheal tube guide mislabeled as a 15 Fr instead of a 10 Fr
Root cause (FDA determination)
Other
Action the firm took
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.
Recalling firm
- Firm
- Smiths Medical ASD, Inc
- Address
- 10 Bowman Dr, Keene, New Hampshire 03431-5043
Distribution
- Distribution pattern
- CA, CO, FL, GA, IN, MA, MD, MI. NH, NC, NY, TX, WA
Timeline
- Recall initiated
- 2004-01-26
- Posted by FDA
- 2004-07-20
- Terminated
- 2012-05-08
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #31341. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.