Devices

Device Recall PneumoSure

Model / Serial
HPUs affected lot numbers 0005051337-000505052795; PneumoSure insufflators affected serial numbers 1510CE0342-1601CE0581
Product Classification
Obstetrical and Gynecological Devices
Device Class
2
Implanted device?
No
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.
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.
Manufacturer
Stryker Endoscopy
1 Event
- Recall of Device Recall PneumoSure

Manufacturer

Stryker Endoscopy

Manufacturer Address
Stryker Endoscopy, 5900 Optical Ct, San Jose CA 95138-1400
Manufacturer Parent Company (2017)
Stryker
Source
USFDA

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