Device 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.
Z-1749-2013
Product summary
- Event
- Event 65492
- Status
- Terminated
- Classification
- Class II
- Quantity
- S099: 171,587 units and S099B: 505,107 units
- Official record key
device-enforcement:Z-1749-2013
Official wording
Reason: 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.
Code information: Models S099 and S099B
Distribution pattern: Worldwide Distribution - USA (nationwide) and Canada.
Derived failure modes
-
Foreign material or chemical contamination
particulate