Edwards Lifesciences, LLC recalls Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for hand held use and pericardia

Recalled July 24, 2013 · FDA recall Z-1749-2013 · Edwards Lifesciences

Hazard

Edwards is recalling certain lots of Rigid Suction Wands because they discovered plastic particulate inside the sterile pouch and within the internal diam ether of the wand. · FDA Class II

Units

S099: 171,587 units and S099B: 505,107 units

Sold at

Worldwide Distribution - USA (nationwide) and Canada.

Description

Edwards is recalling certain lots of Rigid Suction Wands because they discovered plastic particulate inside the sterile pouch and within the internal diam ether of the wand.

Product

Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for hand held use and pericardial sumps are intended for stationary use in removing excess fluid from the surgical field.

Manufacturer(s)

Edwards Lifesciences, LLC

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