Drug recall
Covidien Trellis-6 Peripheral Infusion System. Models BVT608010V01, BVT608030V01, BVT612010V01, and…
FDA recall event 70048 · Class I · Covidien
Key facts
| Event ID | 70048 |
|---|---|
| Recall numbers | Z-1017-2015, Z-1018-2015 |
| Recalling firm | Covidien |
| Product type | Devices |
| Products | Covidien Trellis-6 Peripheral Infusion System. Models BVT608010V01, BVT608030V01, BVT612010V01, and BVT612030V01. Sterile EO. Product Usage: Intended for controlled and selective infusion of…, Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, CVT812015, and CVT812025. The following models are not offered for sale in the US: EVT808015, EVT808025, EVT812015, and… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A manufacturing error resulted in the risk of incorrect proximal and distal balloon inflation port identification on the units. Units have been identified to have the distal balloon inflation port… |
| Initiation date | Dec 10, 2014 |
| Report date | Feb 11, 2015 |
| Termination date | Mar 31, 2016 |
| City | Plymouth |
| State | MN |
| Country | United States |
At a glance
- 1–9 Products in this recall
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: