Z-2092-2017Class II

VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; Model PCE-5012; Qty: 10 each. Anesthesiology...

Name: Z-2092-2017 VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; Model PCE-5012; Qty: 10 each. Anesthesiology...
Creator: Vortran Medical Technology 1, Inc
Published: 2017-04-20
License: https://open.fda.gov/license/

Vortran Medical Technology 1, Inc / initiated 2017-04-20 / Terminated / root cause: manufacturing process

FDA source

Vortran Medical Technology 1, Inc began a recall of VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; Model PCE-5012; Qty: 10 each. Anesthesiology: This device is to be used by properly trained... on 2017-04-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2092-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-20
Posted: 2017-04-25
Terminated: 2017-10-17
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.
Product code: BTL Ventilator, Emergency, Powered (Resuscitator)
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 14 cases (10 each)
Distribution: CA, MS, FL
Product codes and lots: Model PCE 5012; Lot number/ expiry date: 1419 PCE , 2019-03-12; 1434 PCE, 2019-06-04.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2092-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2091-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-24	2017-05-13
Z-2092-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-24	2017-05-13

Product code BTL

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)