Recalls / —

—#43317

Product

Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheostomy Tube, I.D. 8.0 mm O.D. 11.0mm length 130 mm; REF 67HA80.

FDA product code

JOH — Tube Tracheostomy And Tube Cuff

Device class

Class 2

Medical specialty

Anesthesiology

510(k) numbers

K922665

Affected lot / code info

G711880.

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 #43317. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.