Recalls / —
—#49177
Product
Bivona Adult Tracheostomy Tube, I.D. 8.5 mm, O.D 11.0 mm, Length 88 mm, TTS 11.8 mm, Mfrd by Smiths Medical Critical Care; Product code 670185.
- FDA product code
- JOH — Tube Tracheostomy And Tube Cuff
- Device class
- Class 2
- Medical specialty
- Anesthesiology
- 510(k) numbers
- K913859
- Affected lot / code info
- Lots 1008187, 1023402 and 1012767.
Why it was recalled
Mislabeled- The outer diameter (OD) of the shaft is labeled as 11.0 m on the inner, outer and tray label in error. The OD is actually 11.8 mm.
Root cause (FDA determination)
Other
Action the firm took
Distributors and hospital consignees were notified via recall letter dated 8/25/06 to return all unused product to the firm. Distributors were asked to notify their customers of the recall.
Recalling firm
- Firm
- Smiths Medical ASD, Inc.
- Address
- 5700 W 23rd Ave, Gary, Indiana 46406-2617
Distribution
- Distribution pattern
- Worldwide Distribution ---- including USA states of Arkansas, California, Georgia, Illinois, Kansas, Minnesota, Missouri, Ohio, Pennsylvania, Texas and countries of Canada and Netherlands.
Timeline
- Recall initiated
- 2006-08-31
- Posted by FDA
- 2007-01-05
- Terminated
- 2007-05-04
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #49177. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.