Recalls / —
—#144721
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.
- FDA product code
- HIF — Insufflator, Laparoscopic
- Device class
- Class 2
- Medical specialty
- Obstetrics/Gynecology
- 510(k) numbers
- K063367
- Affected lot / code info
- HPUs affected lot numbers 0005051337-000505052795; PneumoSure insufflators affected serial numbers 1510CE0342-1601CE0581
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.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
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.
Recalling firm
- Firm
- Stryker Endoscopy
- Address
- 5900 Optical Ct, San Jose, California 95138-1400
Distribution
- 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.
Timeline
- Recall initiated
- 2016-03-28
- Terminated
- 2016-12-14
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #144721. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.