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.
FDA Recall Z-1967-2012 · Posted 2012-07-09
Recalling FirmEdwards Lifesciences, LLC
Recall StatusTerminated
Product CodeDWF
Date Initiated2012-06-06
Date Terminated2012-09-10
Product Quantity1524 units
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.
Firm Action
Edwards Lifesciences sent an Urgent Field Safety Notice Product Recall letter dated June 2012 to all affected customers. The letter identified the affected product, description of the issue and actions to be taken. Customers were instructed to examine their inventory for the affected product, quarantine and return any remaining in stock and complete the enclosed acknowledgment form with fax instructions to assure that the notification was received. For question call Edwards Customer Service at (800) 424-3278 from 8:00AM-4:30PM Pacific Time.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution - US (nationwide) including the states of CT, TX, CA, AZ, MO, and MD and the countries of Europe and Japan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.