FDA recall Z-2725-2020

Medline Industries Inc · Class II · device

Product

ClearPro Trach T-Piece Closed Suction Catheter, Model DYNCPTP14T, 14 Fr 12.5 IN FOR TRACHEOSTOMY TUBE - Product Usage: Catheters are intended for endotracheal suction of adult patients with artificial airways. Single use only.

Reason for recall

There are reports of the suction catheter coming apart from the device assembly during use.

Distribution

US Nationwide distribution including in the states of AR, AZ, CA, FL, GA, IL, MS, NY, NV, OH, PA, TX.

Key facts

Status
Ongoing
Initiation date
2020-06-30
Report date
2020-08-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2725-2020