Recall Z-1566-2016 ยท HIF Insufflator, Laparoscopic
Stryker Endoscopy
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 laparosc
| Date | Mar 28, 2016 |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | Urgent Medical Device Recall letters were sent to domestic customers on March 28, 2016 by certified mail. Stryker International distribution sites were notified and are responsible for providing information to affected customers. |
| Quantity | 489 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063367 | 45L CORE INSUFFLATOR, MODEL F114 W.O.M. World of Medicine AG, May 23, 2007 |