—#49817

Product

Bivona Laryngectomy Tube, Cuffless, Silicone, I.D. 9.5 mm, O.D 20.0 mm, Length 85 mm, Mfrd by Smiths Medical Critical Care; REF BOSL1L.

FDA product code: KAC — Tube, Laryngectomy
Device class: Class 1
Medical specialty: Ear, Nose, Throat
Affected lot / code info: Lots 1055779, 1245930, 1263830, 1302670, 1310500, 1324570, 1351420, 1351480, G654810, G689730 and G726388.

Why it was recalled

The label incorrectly states the outer diameter of the tube is 20.0 mm when it is actually 12.0 mm.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified via recall letter dated 12/15/06. Distributors were requested to provide the firm with final user name and address information so that they could notify them of the recall. The firm is advising users that they can either return the product for replacement or continue to use it now that they are aware of the labeling error.

Recalling firm

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

Distribution

Distribution pattern: Worldwide, including USA, Canada, Netherlands and United Kingdom.

Timeline

Recall initiated: 2006-12-15
Posted by FDA: 2007-01-25
Terminated: 2007-12-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #49817. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.