FDA recall Z-2826-2018

Product

The Tri-Flo Subglottic Suction System

Reason for recall

Vyaire Medical has discovered potential patient safety risk with associated with the Tri-Flow Subglottic Suction System. The distal soft tip of the catheter has been identified as having the potential to break off during patient use and result in aspiration of a solid foreign body.

Distribution

Domestic Distribution: AZ, CA, CT, FL, GA, IA, IL, IN, MA, MD, MN, NJ, OH, OK, SD, TX, WA, WI.

Key facts

Status

Terminated

Initiation date

2018-06-20

Report date

2018-08-29

Termination date

2020-07-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mettawa, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2826-2018