FDA-Device2026-01-21Class II
Medline medical procedure convenience kits labeled as: 1) THORACIC ROBOTICS, REF DYNJ908777B; 2) CARDIAC ROBOTIC WHC KIT-LF, REF DYNJ911359
Medline Industries, LP
Hazard
Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.
Sold states
US Nationwide distribution.
Affected count
96 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline medical procedure convenience kits labeled as: 1) THORACIC ROBOTICS, REF DYNJ908777B; 2) CARDIAC ROBOTIC WHC KIT-LF, REF DYNJ911359
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1085-2026Don't want to check this manually?
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