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Device Recall StrykeFlow 2 suction/irrigator
Model / Serial
a. Model 0250070500, Product Code GCJ, UDI 07613327061390, Lot No. 17275FG2, 17276FG2, 17277FG2, 17278FG2, 17279FG2, 17280FG2, 17283FG2, 17284FG2, 17285FG2, 17286FG2, 17289FG2, 17290FG2, 17291FG2, 17292FG2, 17293FG2, 17294FG2, 17297FG2, 17299FG2, 17301FG2); 0250070505, 0250070520; b. Model 0250070505, Product Code GCX, UDI 07613327061406, Lot No. 17294FG2; c. Model 0250070520, Product Code GCX, UDI 07613327061369, Lot No. 17282FG2, 17283FG2, 17286FG2, 17289FG2, 17290FG2, 17292FG2, 17293FG2, 17294FG2, 17296FG2, 17297FG2, 17298FG2, 17299FG2, 17300FG2, 17301FG2, 17302FG2
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
Distributed domestically to . Distributed internationally to Australia and Mexico.
Product Description
StrykeFlow 2 System, labeled sterile. Includes the following: || a. STRYKER LAPAROSCOPIC SUCTION IRRIGATOR, Suction/Irrigator 2 (Model 0250070500); || b. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Disposable Strykeflow S/I Tip (Model 0250070505); || c. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Strykeflow 2 with Tip (Model 0250070520) || STRYKER LAPAROSCOPIC SUCTION IRRIGATOR
Manufacturer
Stryker Corporation
1 Event
Recall of Device Recall StrykeFlow 2 suction/irrigator
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Manufacturer
Stryker Corporation
Manufacturer Address
Stryker Corporation, 5900 Optical Ct, San Jose CA 95138-1400
Manufacturer Parent Company (2017)
Stryker
Source
USFDA
Language
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