—#48075

Product

Bivona Adult Tracheostomy Tube, Labeled I.D. 6.0 mm, O.D. 8.7 mm, A 7.0 mm, B 0 mm, C 53.0 mm, Mfrd by Smiths Medical Critical Care; REF 60A160.

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 1037018 and 1045416.

Why it was recalled

The length of the shaft is incorrectly stated as 7 mm, instead of the correct 17 mm, on the outer packaging, although the tray label is correct.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified to cease using, and to return the product, by recall letter dated August 2006 and mailed on 8/11/06.

Recalling firm

Firm: Smiths Medical ASD, Inc.
Address: 5700 W 23rd Ave, Gary, Indiana 46406-2617

Distribution

Distribution pattern: Nationwide.

Timeline

Recall initiated: 2006-08-11
Posted by FDA: 2006-10-19
Terminated: 2007-12-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #48075. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.