FDA recall Z-0058-2021

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 for recall

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

Distribution

62 US consignees; 1 government consignee, 4 foreign consignees

Key facts

Status

Terminated

Initiation date

2020-09-01

Report date

2020-10-14

Termination date

2022-05-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0058-2021