—#43315

Product

Bivona brand Mid-Range Aire-Cuf Adjustable Neck Flange Hyperflex Tracheostomy Tube, I.D. 6.0 mm O.D. 8.7 mm length 110 mm; REF 75HA60.

FDA product code: JOH — Tube Tracheostomy And Tube Cuff
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K922665
Affected lot / code info: Lot G706181.

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 #43315. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.