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.
- Recall Initiated
- August 19, 2019
- Recall Number
- Z-1443-2020
- Quantity
- 723 cases (7230 units)
- Firm Location
- Los Angeles, CA
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
Lot / Code Info
Lot KS1901013: 20019/03/31 - 06/192019 Lot KS1902002: 2019/06/21 - 07/31/2019
Root Cause
Component change control
Action Taken
On 8/19/19 a recall notice was sent to all affected customers. The letter outlined the recall issue and requested that customers complete the enclosed form for the return of the products (new and used) and the issuance of replacement product or credit.