Recalls / —

—#41073

Product

Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheostomy Tubes, sterile, Product 67HA70.

FDA product code

BTO — Tube, Tracheostomy (W/Wo Connector)

Device class

Class 2

Medical specialty

Anesthesiology

510(k) numbers

K894614

Affected lot / code info

Lot G667991.

Why it was recalled

Instructions for use included in the package are for a different tracheostomy tube.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified via 'precautionary product advisory notification' letter dated July 25, 2005.

Recalling firm

Firm

Smiths Medical ASD, Inc.

Address

5700 W 23rd Ave, Gary, Indiana 46406-2617

Distribution

Distribution pattern

Nationwide.

Timeline

Recall initiated

2005-07-25

Posted by FDA

2005-12-23

Terminated

2007-12-04

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #41073. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.