FDA recall Z-1443-2020

RESPIRATORY THERAPEUTICS GROUP LLC · Class II · device

Product

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.

Reason for recall

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.

Distribution

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

Key facts

Status
Ongoing
Initiation date
2019-08-19
Report date
2020-03-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Los Angeles, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1443-2020