Recall Z-1967-2012 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Edwards Lifesciences, LLC
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.
| Date | Jul 9, 2012 (initiated Jun 6, 2012) |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| 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. |
| Quantity | 1524 units |
| Distribution | Worldwide Distribution - US (nationwide) including the states of CT, TX, CA, AZ, MO, and MD and the countries of Europe and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K831759 | INTRACARDIA SUCKERS Research Industries Corp., Aug 12, 1983 |