Smiths Medical ASD Inc. recalls UniPerc(R) Adjustable Flange Tracheostomy Tube kit, Reorder Number 100/897/080 CZ The UniPerc(R) Tracheostomy Tubes can…

Recall date

August 14, 2017

Source

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

Recall number

Z-3213-2017

FDA classification

Class II

Brand / firm

Smiths Medical ASD Inc.

Sold / distributed

INTERNATIONAL ONLY: GB, FR, AT, DE, IT, SE, IE, BE, ES, LU

Why it was recalled

Smiths Medical became aware that one lot of the 8.0mm UniPerc(R) Adjustable Flange Tracheostomy Tube kit, product reorder number 100/897/080 CZ, lot number 3308971, contains an incorrect 9.0mm sized obturator instead of the correct 8.0mm sized obturator.

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

What was recalled

UniPerc(R) Adjustable Flange Tracheostomy Tube kit, Reorder Number 100/897/080 CZ The UniPerc(R) Tracheostomy Tubes can be used during the surgical placement of a stoma or as a replacement tube to an already existing stoma for patients with larger necks. The tracheostomy tubes are removed and may be replaced after no more than 30 days with an identical device. The range may include the following configurations: cuffed or uncuffed tracheostomy tubes, tracheostomy tube inner cannula, cleaning brushes and tracheostomy tube holder.