RESPIRATORY THERAPEUTICS GROUP LLC recalls RespVent Closed Suction System T-Piece Tracheostomy Adult, Diameter: 4.6mm (14F), Length: 30.5cm (12in.), MDI Adapter,…

Recall date

August 19, 2019

Source

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

Recall number

Z-1443-2020

FDA classification

Class II

Brand / firm

RESPIRATORY THERAPEUTICS GROUP LLC

Sold / distributed

US Nationwide distribution in the states of CA, NJ, NY. OUS: None

Why it was recalled

It has been determined that some units of catheters were not tightly connected to the thumb port. This may result in the catheter disconnecting from the thumb port which could reduce the suction performance and make it difficult to remove from the patient's trachea.

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

What was recalled

RespVent Closed Suction System T-Piece Tracheostomy Adult, Diameter: 4.6mm (14F), Length: 30.5cm (12in.), MDI Adapter, Cont. 10 Closed Suction Catheter, Sterile R, RxOnly, Reorder Number: RTG-02300, UDI: 00850108006035 - Product Usage: To be used to aspirate liquids or semi solids from a patient s upper airway.