Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for hand held use and pericardial s

FDA device recall Z-1749-2013 · posted 2013-07-17 · Terminated

Recall details

Recalling firm

Edwards Lifesciences, LLC

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.

Action taken

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.

Root cause

Component design/selection

Status

Terminated

Product code

DWF

Quantity affected

S099: 171,587 units and S099B: 505,107 units

Distribution

Worldwide Distribution - USA (nationwide) and Canada.

Date initiated

2013-06-19

Date posted

2013-07-17

Date terminated

2014-11-04

Location

Draper, UT

Related 510(k) clearances