—#43316

Product

Bivona brand Mid-Range Aire-Cuf Extra Length Fixed Hyperflex Adult Tracheostomy Tube, I.D. 8.0 mm O.D. 11.0mm length 120 mm; REF 75FHXL80.

FDA product code: JOH — Tube Tracheostomy And Tube Cuff
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K922665
Affected lot / code info: Lots G711870 and G711871.

Why it was recalled

Sterility is compromised by incomplete package seal.

Root cause (FDA determination)

Other

Action the firm took

Certified letters were sent to each consignee on 12/ 16/05 and distributors were requested 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: Nationwide and Canada.

Timeline

Recall initiated: 2005-12-16
Posted by FDA: 2006-01-18
Terminated: 2007-02-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #43316. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.