Reported May 24, 2017 · Terminated
VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; Model PCE-5012; Qty: 10 each. Anesthesiology: This device…
Vortran Medical Technology 1, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Vortran Medical Technology 1, Inc · 21 Goldenland Court Ste 100 · Sacramento, CA · 95834-2427
Is this the product you have?
- VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; Model PCE-5012
- Qty10 each
- AnesthesiologyThis device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilatory support
- Lot codes and dates
- Model PCE 5012
- Lot number/ expiry date
1419 PCE2019-03-121434 PCE2019-06-04
- Amount recalled
- 14 cases (10 each)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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