FDA-Device2020-03-11Class II
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.
RESPIRATORY THERAPEUTICS GROUP LLC
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.
Sold states
US Nationwide distribution in the states of CA, NJ, NY. OUS: None
Affected count
723 cases (7230 units)
Manufactured in
5670 Wilshire Blvd Ste 1803, N/A, Los Angeles, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1443-2020Don't want to check this manually?
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