Boston Scientific product recalled over labeling errors

Recall date

March 18, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Boston Scientific Corporation recalls Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm X 30mm Material Number: M00576550 The ste…

Recall number

Z-1567-2016

FDA classification

Class II

Brand / firm

Boston Scientific Corporation

Sold / distributed

Nationwide Distribution to AL, CA, MA, and TX.

Why it was recalled

Mislabeled: 10mm diameter x 30mm length Ultraflex Tracheobronchial stents were labeled as 12mm diameter x 30mm

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm X 30mm Material Number: M00576550 The stent system is a permanently implanted expandable metal stent designed for palliation of tracheobronchial (TB) strictures. The system consists of a flexible delivery catheter preloaded with an expandable metal stent. The stent is offered in a variety of sizes of different diameters and lengths