FDA-Device2020-08-05Class II

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.

Medline Industries Inc
Hazard

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

Sold states
US Nationwide distribution including in the states of AR, AZ, CA, FL, GA, IL, MS, NY, NV, OH, PA, TX.
Affected count
680 units
Manufactured in
Three Lakes Drive, N/A, Northfield, IL, United States
Products
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.

Official notice

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

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