Drug recall
RespVent Closed Suction System T-Piece Tracheostomy Adult, Diameter: 4.6mm (14F), Length: 30.5cm (12in.), MDI…
FDA recall event 84859 · Class II · RESPIRATORY THERAPEUTICS GROUP LLC
Key facts
| Event ID | 84859 |
|---|---|
| Recall numbers | Z-1443-2020 |
| Recalling firm | RESPIRATORY THERAPEUTICS GROUP LLC |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Aug 19, 2019 |
| Report date | Mar 11, 2020 |
| City | Los Angeles |
| State | CA |
| Country | United States |
| FEI number | 3011285025 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: