Recalls / —

—#41075

Product

Bivona brand Neonatal TTS Tracheostomy Tubes, sterile, product code 67N040.

FDA product code

BTO — Tube, Tracheostomy (W/Wo Connector)

Device class

Class 2

Medical specialty

Anesthesiology

510(k) numbers

K914088

Affected lot / code info

Lot 1338010.

Why it was recalled

The word PED was printed on the neckflange instead of the word NEO.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified via 'product advisory letter' dated 2/17/05 and requested to either notify all users or to return the product for replacement.

Recalling firm

Firm

Smiths Medical ASD, Inc.

Address

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

Distribution

Distribution pattern

Georgia, Illinois, Indiana, Maryland, Tennessee, Texas and Virginia.

Timeline

Recall initiated

2005-02-17

Posted by FDA

2005-12-23

Terminated

2007-12-04

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #41075. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.