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.
Reason for recall: 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. Distribution: US Nationwide distribution. Quantity: 12 units Lot/code info: UDI/DI 10198459156991 (EA) 40198459156992 (CS), Lot Number 25EBM426
10198459156991, 40198459156992
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.