Sorin Group USA, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1985-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs.

Product Classification:

Class II

Date Initiated: July 8, 2013

Date Posted: August 28, 2013

Recall Number: Z-1985-2013

Event ID: 65869

Reason for Recall:

Sorin Group is recalling certain lots of Edwards Lifesciences Suction Wand Model S099B due to presence of plastic particles inside the pouch.

Status: Terminated

Product Quantity: 18,927 packs

Code Information:

Model S099B

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated