Stryker Endoscopy recalls Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Sterile, Rx only, Latex Free. Stryker Suction Irr

Recalled July 30, 2014 · FDA recall Z-2080-2014 · Stryker Endoscopy

Hazard

Internal review found that six lots of Disposable StrykeFlow Tips were shipped with a potentially deformed blister pouch which could impact sterility of the product. · FDA Class II

Units

496 boxes (6 tips per box)

Sold at

Worldwide Distribution - USA (nationwide) and Internationally tAustralia, Canada, France, Greece, Netherlands, United kingdom and South Korea.

Description

Internal review found that six lots of Disposable StrykeFlow Tips were shipped with a potentially deformed blister pouch which could impact sterility of the product.

Product

Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Sterile, Rx only, Latex Free. Stryker Suction Irrigation system, used to provide a clean and clear operative site through the evacuation and aspiration of irrigant solution. for endoscopic use.

Manufacturer(s)

Stryker Endoscopy

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