Stryker Corporation recalls StrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER LAPAROSCOPIC SUCTION IRRIGATOR, Suction/Irr

Recalled March 14, 2018 · FDA recall Z-0835-2018 · Stryker

Hazard

Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates. · FDA Class II

Units

60,753 units total

Sold at

Distributed domestically to . Distributed internationally to Australia and Mexico.

Description

Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.

Product

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(s)

Stryker Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →