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
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-0835-2018More Stryker Corporation recalls
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