Recall Z-1985-2013— Sorin Group USA, Inc.

Name: FDA recall Z-1985-2013
Creator: U.S. Food and Drug Administration
Published: 2013-07-08

Class II · Terminated

Class II FDA medical device recall by Sorin Group USA, Inc., initiated 2013-07-08, terminated 2014-01-28. It names one FDA 510(k) clearance: K881330. Product: Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs.. Reason: Sorin Group is recalling certain lots of Edwards Lifesciences Suction Wand Model S099B due to presence of plastic particles inside the pouch..

Recalling firm: Sorin Group USA, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-07-08
Terminated: 2014-01-28
Firm location: Arvada, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K881330 — COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACKCobe Laboratories, Inc.·cleared 1988-06-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.