Recall Z-1443-2020— RESPIRATORY THERAPEUTICS GROUP LLC
Class II · Ongoing
Class II FDA medical device recall by RESPIRATORY THERAPEUTICS GROUP LLC, initiated 2019-08-19. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- RESPIRATORY THERAPEUTICS GROUP LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2019-08-19
- Firm location
- Los Angeles, CA, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.