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RESPIRATORY THERAPEUTICS GROUP LLC recalls RespVent Closed Suction System T-Piece Tracheostomy Adult, Diameter: 4.6mm (14F), Length: 30.5cm (12in.), MDI Adapter, C
Recalled March 11, 2020 · FDA recall Z-1443-2020 · RESPIRATORY THERAPEUTICS GROUP
Hazard
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. · FDA Class II
Units
723 cases (7230 units)
Sold at
US Nationwide distribution in the states of CA, NJ, NY. OUS: None
Description
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.
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.
Manufacturer(s)
RESPIRATORY THERAPEUTICS GROUP LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →