Recall Z-0058-2021— Medline Industries Inc

Class II · Terminated

Class II FDA medical device recall by Medline Industries Inc, initiated 2020-09-01, terminated 2022-05-27. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: There have been reports of the suction catheter coming apart from the device assembly during use..

Recalling firm
Medline Industries Inc
Classification
Class II
Status
Terminated
Initiated
2020-09-01
Terminated
2022-05-27
Firm location
Northfield, IL, United States

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.