Reported May 4, 2016 · Terminated
PneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator; High pressure units (HPU) (40L and 45L).…
Stryker Endoscopy
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: Stryker Endoscopy · 5900 Optical Ct · San Jose, CA · 95138-1400
Is this the product you have?
4 of 4 products
| # | Product as published |
|---|---|
| 1 | PneumoSure XL High Flow Insufflator and |
| 2 | PneumoSure High Flow Insufflator; High pressure units (HPU) (40L and 45L). |
| 3 | Model Numbers: 620-040-610, 620-040-611, 620-040-613, 620-040-614, 620-040-600, 620-040-601, 620-040-602, 620-040-604, 105-210-684 The |
| 4 | Pneumo Sure XL High Flow Insufflator is a device that serves to create a cavity by insufflating CO2 during diagnostics and/or therapeutic laparoscopy. The insufflator consists of a console, that is intended to be connected to a CO2 gas source, and has a tubeset inserted to transport CO2 gas from the insufflator to the connecting trocar. |
- Lot codes and dates
- HPUs affected lot numbers 0005051337-000505052795; PneumoSure insufflators affected serial numbers 1510CE0342-1601CE0581
- Amount recalled
- 489
Where it was sold
- Nationwide
- PR
Why it was recalled
When operating the device in high flow mode (40L/min, 15 mmHg) and connecting to a house gas inlet source, within seconds of insufflating the flow rate would drop to 0L/min and the red Check Gas Supply symbol would appear on the display, immediately suspending insufflation.
This product could cause temporary or reversible health problems — stop using it.
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