Drug recall
VORTRAN Automatic Resuscitator, VARPlus; Model PTE-5002; Qty: 10 each Anesthesiology: This device is to be…
FDA recall event 77072 · Class II · Vortran Medical Technology 1, Inc
Key facts
| Event ID | 77072 |
|---|---|
| Recall numbers | Z-2091-2017, Z-2092-2017 |
| Recalling firm | Vortran Medical Technology 1, Inc |
| Product type | Devices |
| Products | VORTRAN Automatic Resuscitator, VARPlus; Model PTE-5002; Qty: 10 each Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure…, VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; Model PCE-5012; Qty: 10 each. Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Vortran received a customer complaint that the spin-nut-DSS connector was assembled in the reverse direction on the oxygen tubing; making the connector unable to be screwed on due to the wrong thread… |
| Initiation date | Apr 20, 2017 |
| Report date | May 24, 2017 |
| Termination date | Oct 17, 2017 |
| City | Sacramento |
| State | CA |
| Country | United States |
| FEI number | 1000307109 |
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: