Recall Z-1443-2020 ยท BSY Catheters, Suction, Tracheobronchial
RESPIRATORY THERAPEUTICS GROUP LLC
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.
| Date | Aug 19, 2019 |
| Status | Open, Classified |
| 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. |
| Root cause | Component change control |
| Action | 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. |
| Quantity | 723 cases (7230 units) |
| Distribution | US Nationwide distribution in the states of CA, NJ, NY. OUS: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.