Medline Industries Inc recalls ClearPro Closed Suction Catheter, Model DYNCPDS14T, 14 Fr FOR ENDOTRACHEAL TUBE - Product Usage: Catheters are intended…

Recall date

September 1, 2020

Source

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

Recall number

Z-0058-2021

FDA classification

Class II

Brand / firm

Medline Industries Inc

Sold / distributed

62 US consignees; 1 government consignee, 4 foreign consignees

Why it was recalled

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

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

What was recalled

ClearPro Closed Suction Catheter, Model DYNCPDS14T, 14 Fr FOR ENDOTRACHEAL TUBE - Product Usage: Catheters are intended for endotracheal suction of adult patients with artificial airways. Single use only.