FDA recall Z-3213-2017

Product

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.

Reason for recall

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2017-08-14

Report date

2017-10-04

Termination date

2019-06-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3213-2017