Recalls / —

—#44606

Product

Blue Line Ultra Tracheostomy Tube 8.00mm Inner Cannula REF 100/858/080

FDA product code

BTO — Tube, Tracheostomy (W/Wo Connector)

Device class

Class 2

Medical specialty

Anesthesiology

510(k) numbers

K030381

Affected lot / code info

Lot 490694

Why it was recalled

Mislabeled Product labeled as 8.0mm inner cannula, may contain a 9.0mm

Root cause (FDA determination)

Other

Action the firm took

Smiths Medical ASD, Inc. notified US customers by letter dated 3/7/06. Accounts are requested to return inventory.

Recalling firm

Firm

Smiths Medical ASD, Inc.

Address

10 Bowman Dr, Keene, New Hampshire 03431-5043

Distribution

Distribution pattern

Nationwide

Timeline

Recall initiated

2006-03-07

Posted by FDA

2006-04-06

Terminated

2012-05-08

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #44606. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.