Z-1443-2020 Class II Ongoing
FDA device recall Z-1443-2020 was initiated by RESPIRATORY THERAPEUTICS GROUP LLC on August 19, 2019 and is designated Class II. 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 perfo… The recall status is ongoing. Affected quantity: 723 cases (7230 units).
Recall Details
- Product Type
- Devices
- Report Date
- March 11, 2020
- Initiation Date
- August 19, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 723 cases (7230 units)
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.
Distribution Pattern
US Nationwide distribution in the states of CA, NJ, NY. OUS: None
Code Information
Lot KS1901013: 20019/03/31 - 06/192019 Lot KS1902002: 2019/06/21 - 07/31/2019