Edwards Lifesciences Fogaty Occlusion Catheter Ref # 62080822F. The product is intended for use in Temporary Vessel Occl

FDA device recall Z-0002-2010 · posted 2009-11-10 · Terminated

Recall details

Recalling firm

Edwards Lifesciences, Llc

Reason for recall

Several complaints were the two parts of the tubular package became loose under the shrink wrap that holds the DFU on the packaging tube.

Action taken

Edwards initiated a worldwide recall via customer letter dated June 29, 2009, sent via Federal express on same day, requesting that customers cease using Fogarty Occlusion Catheter, Model No. 62080822F products from the indicated lots and that they return all unused products. Edwards requested that the customers provide written verification of stock and identify any unused products to be returned to Edwards Lifesciences LLC, Att: Field Action Coordinator, ODW Logistics, Inc., 13725 Pipeline Ave., Chino, CA 91710. Additionally provided Customer Service Tel # 800.424.3278.

Root cause

Packaging change control

Status

Terminated

Product code

MFC

Quantity affected

9548

Distribution

AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD MI MN MO MS MO NC ND NE NH NJ NM NV NK OH OR PA RI SC SD TN TX UT VA VT WA WI WV WY, Puerto Rico Australia, Belgium, Brazil, Bulgaria, Canad

Date initiated

2009-06-22

Date posted

2009-11-10

Date terminated

2012-02-23

Location

Irvine, CA