Recalls / —

—#41074

Product

Bivona brand Cuffless Extra Length Fixed Hyperflex Adult Tracheostomy Tube, 110 mm, sterile, Product code 60AFHXL70.

FDA product code

BTO — Tube, Tracheostomy (W/Wo Connector)

Device class

Class 2

Medical specialty

Anesthesiology

510(k) numbers

K922665

Affected lot / code info

Lot G653628.

Why it was recalled

The shaft was manufactured approximately 1 to 3 mm under the length specification, and may be 105 mm in length.

Root cause (FDA determination)

Other

Action the firm took

Consignee was notified via recall letter dated April 19, 2005.

Recalling firm

Firm

Smiths Medical ASD, Inc.

Address

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

Distribution

Distribution pattern

California, Indiana and North Carolina.

Timeline

Recall initiated

2005-04-19

Posted by FDA

2006-01-06

Terminated

2007-12-06

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #41074. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.