FDA Medical Device Recalls (openFDA)
Vortran Medical Technology 1, Inc: 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.
- Recall number
- Z-2092-2017
- Recalling firm
- Vortran Medical Technology 1, Inc
- 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.
- Status
- Terminated
- Initiated
- 2017-04-20
- Posted
- 2017-04-25
- Terminated
- 2017-10-17
- 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.
- Root cause
- Process control
- Action
- Medical Device Recall letters were sent on April 20, 2017. Letters explained the reason for recall and listed the specific lots sent to each distributor along with dates, PO numbers and quantity. Vortran Medical asks that each distributor provide a list of customers who received the affected product so that they can notify them directly of the recall.
- Quantity
- 14 cases (10 each)
- Distribution
- CA, MS, FL
- Lot, serial or model codes
- Model PCE 5012; Lot number/ expiry date: 1419 PCE , 2019-03-12; 1434 PCE, 2019-06-04.
- 510(k) numbers
- ["K001430","K041473","K973975"]
- PMA numbers
- not on file
- Product code
- BTL
- Firm FEI
- 1000307109
- Firm city
- Sacramento
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28