—#119271

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.

FDA product code: DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K831759
Affected lot / code info: Models S099 and S099B

Why it was recalled

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.

Root cause (FDA determination)

Component design/selection

Action the firm took

Edwards sent an Urgent Field Safety Notice Product Recall letter, dated June 19, 2013, via FedEx to all affected customers. Two additional attempts will be made to notify customers to return products. The letter idenditifed the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory for any affected device in their inventory, quarantine all affected product from their inventory and return all devices to Edwards. Customers were instructed to acknowledge that they have reviewed the Recall Notice and confirm that they have taken appropriate action by completing, sign and dating the enclosed Recall Response Form and returning the form to Edwards by fax to Edwards Customer Service at 800-422-9329. Customers should contact Customer Service at 800-424-3278 to obtain a Returned Goods Authorization number to return their current product to and receive replacement product. Customers with questions were instructed to call Edwards Customer Service at 800-424-3278.

Recalling firm

Firm: Edwards Lifesciences, LLC
Address: 12050 Lone Peak Pkwy, Draper, Utah 84020-9414

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) and Canada.

Timeline

Recall initiated: 2013-06-19
Posted by FDA: 2013-07-17
Terminated: 2014-11-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #119271. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.