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.
Z-1443-2020
Product summary
- Event
- Event 84859
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 723 cases (7230 units)
- Official record key
device-enforcement:Z-1443-2020
Official wording
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.
Code information: Lot KS1901013: 20019/03/31 - 06/192019 Lot KS1902002: 2019/06/21 - 07/31/2019
Distribution pattern: US Nationwide distribution in the states of CA, NJ, NY. OUS: None
Derived failure modes
-
Unknown
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.