Home / Recalls / Stryker Endoscopy / Z-1566-2016

Z-1566-2016 Class II Terminated

Recalled by Stryker Endoscopy — San Jose, CA

Recall Details

Product Type
Devices
Report Date
May 4, 2016
Initiation Date
March 28, 2016
Termination Date
December 14, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
489

Product Description

PneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator; High pressure units (HPU) (40L and 45L). 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 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.

Reason for Recall

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.

Distribution Pattern

Worldwide distribution. US nationwide including Puerto Rico, China, Hong Kong, India, Japan, Korea, Romania, Vietnam, Singapore, Taiwan, Netherlands, Peru, Australia, Canada, Mexico, Argentina, Chile, Poland, South Africa, and Guatemala.

Code Information

HPUs affected lot numbers 0005051337-000505052795; PneumoSure insufflators affected serial numbers 1510CE0342-1601CE0581

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