FDA-Device2018-03-14Class II
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
Stryker Corporation
Hazard
Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
Sold states
Distributed domestically to . Distributed internationally to Australia and Mexico.
Affected count
60,753 units total
Manufactured in
5900 Optical Ct, N/A, San Jose, CA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0835-2018Don't want to check this manually?
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