Class II — Vortran Medical Technology 1, Inc
| Recalling firm | VORTRAN MEDICAL TECHNOLOGY 1, INC. |
|---|---|
| Registered facility | VORTRAN MEDICAL TECHNOLOGY 1, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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 direction. |
| Product | 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 cycled ventilatory support. |
| Quantity | 35 cases (10 each) |
| Distribution | CA, MS, FL |
| Initiated | 2017-04-20 |
| Classified | 2017-05-13 |
| Terminated | 2017-10-17 |
| Recall number | Z-2091-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Vortran Medical Technology 1, Inc (Z-2091-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77072/
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