VORTRAN Automatic Resuscitator — Class II medical device recall Z-2092-2017
Terminated recall by Vortran Medical Technology 1, Inc, reported 2017-05-24, distributed in CA, FL, MS. Vortran received a customer complaint that the spin-nut-DSS connector was assembled in the reverse direction o
| Recall number | Z-2092-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vortran Medical Technology 1, Inc, Sacramento, CA, United States |
| Recall initiated | 2017-04-20 |
| Classified | 2017-05-13 |
| Reported by FDA | 2017-05-24 |
| Terminated | 2017-10-17 |
| Distributed | CA, FL, MS |
| Lot numbers | 1419PCE, 1434PCE |
| Model numbers | 5012, PCE-5012 |
Product
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, constant flow, pressure cycled ventilatory support.
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 direction.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2092-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.