Recalls / —

—#38630

Product

Bivona brand Pediatric TTS Tracheostomy Tube, 3.5 mm tracheostomy tubes with a 3.5mm obturator ; product code 67P035.

FDA product code

JOH — Tube Tracheostomy And Tube Cuff

Device class

Class 2

Medical specialty

Anesthesiology

510(k) numbers

K914088

Affected lot / code info

Lot G651610.

Why it was recalled

The obturator may be 3.0 mm in length instead of the labeled 3.5 mm.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified via letter dated 4/26/05.

Recalling firm

Firm

Smiths Medical ASD, Inc.

Address

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

Distribution

Distribution pattern

Connecticut, Georgia, Illinois, Indiana, Minnesota, Missouri, New Mexico, and North Carolina.

Timeline

Recall initiated

2005-04-26

Posted by FDA

2005-06-25

Terminated

2005-10-26

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #38630. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.