Recall Z-1749-2013— Edwards Lifesciences, LLC

Name: FDA recall Z-1749-2013
Creator: U.S. Food and Drug Administration
Published: 2013-06-19

Class II · Terminated

Class II FDA medical device recall by Edwards Lifesciences, LLC, initiated 2013-06-19, terminated 2014-11-04. It names one FDA 510(k) clearance: K831759. 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.. 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..

Recalling firm: Edwards Lifesciences, LLC
Classification: Class II
Status: Terminated
Initiated: 2013-06-19
Terminated: 2014-11-04
Firm location: Draper, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K831759 — INTRACARDIA SUCKERSResearch Industries Corp.·cleared 1983-08-12

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, 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.

Reason for recall

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.

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