Recall Z-1967-2012— Edwards Lifesciences, LLC

Name: FDA recall Z-1967-2012
Creator: U.S. Food and Drug Administration
Published: 2012-06-06

Class II · Terminated

Class II FDA medical device recall by Edwards Lifesciences, LLC, initiated 2012-06-06, terminated 2012-09-10. It names one FDA 510(k) clearance: K831759. Product: Edwards Lifesciences Rigid Suction Wand, sterile. Model numbers S033 and SPC2081. Product Usage: These suction catheters are typically used to remove fluid on the external surface of the heart during cardiac surgery and therefore there is little risk of intravascular involvement.. Reason: Edwards is recalling Suction Wand models SPC2081 and S033 because the plastic tip attached to the metal suction wand may become detached during routine use..

Recalling firm: Edwards Lifesciences, LLC
Classification: Class II
Status: Terminated
Initiated: 2012-06-06
Terminated: 2012-09-10
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 Rigid Suction Wand, sterile. Model numbers S033 and SPC2081. Product Usage: These suction catheters are typically used to remove fluid on the external surface of the heart during cardiac surgery and therefore there is little risk of intravascular involvement.

Reason for recall

Edwards is recalling Suction Wand models SPC2081 and S033 because the plastic tip attached to the metal suction wand may become detached during routine use.

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