Recall Z-1566-2016— Stryker Endoscopy

Name: FDA recall Z-1566-2016
Creator: U.S. Food and Drug Administration
Published: 2016-03-28

Class II · Terminated

Class II FDA medical device recall by Stryker Endoscopy, initiated 2016-03-28, terminated 2016-12-14. It names one FDA 510(k) clearance: K063367. Product: 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: 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..

Recalling firm: Stryker Endoscopy
Classification: Class II
Status: Terminated
Initiated: 2016-03-28
Terminated: 2016-12-14
Firm location: San Jose, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K063367 — 45L CORE INSUFFLATOR, MODEL F114W.O.M. World of Medicine AG·cleared 2007-05-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.