Device product
Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs.
Z-1985-2013
Product summary
- Event
- Event 65869
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18,927 packs
- Official record key
device-enforcement:Z-1985-2013
Official wording
Reason: Sorin Group is recalling certain lots of Edwards Lifesciences Suction Wand Model S099B due to presence of plastic particles inside the pouch.
Code information: Model S099B
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Foreign material or chemical contamination
plastic particles