FDA Device Recall Z-0013-2009: Edwards Lifesciences, LLC

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0013-2009.

Recall Res Number

Z-0013-2009

Recalling Firm / Manufacturer

Edwards Lifesciences, LLC

FEI Number

2015691

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2008-06-23

Date Posted

2008-10-03

Date Terminated

2012-09-19

Product Code

MJN

Event Number

49003

Product Quantity

2,975 units

Product Description Edwards Lifesciences***Fogarty Fortis***Arterial Embolectomy Catheter Is indicated for the removal of fresh, soft emboli and thrombi from the vessels in the arterial system.

Reason for Recall Potential for tubing fracture near the tip of the catheter.

Action Details The firm sent Urgent Field Safety Notices dated June 23, 2008 to customers. The letter gave details on affected products, a description of the problem, and advise on action to be taken. Edwards has decided to recall these lots of Fogarty Fortis catheters which were manufactured between 9 June 2007 and 20 June 2008. The expiration date for these lots is between 11 September 2009 and 26 September 2009. The attached sheet lists product by model and lot number which you have ordered during that time frame. Please stop using these lots of catheter products immediately. Edwards requests that you return all Fogarty Fortis catheters from these lots that are still in your inventory. Please call Edwards Customer Service to arrange for return of any unused product and obtain information about replacement product. After you have verified your inventory, please complete the attached Confirmation Form, even if you no longer have any affected units at your facility. This will allow us to verify the completion of this recall action. Please return the Confirmation Form by FAX to: +31.412.47.66.99 , Attention: Mark vanSchijndel Transmission of this Field Safety Notice: This notice needs to be passed on all those who need to be aware within your organization. Please transfer this notice to other organizations on which this action has an impact and where or to any organization where the potentially affected devices have been transferred. Please maintain awareness on this notice and resulting action for an appreciate period to ensure effectiveness of the corrective action. We sincerely regret the inconvenience caused by this action and greatly appreciate your immediate attention to this matter. If you have specific questions about this notification, please contact Customer Service

Distribution Pattern International Distribution --- including countries of Austria, Belgium, Bulgaria, Switzerland, Czech republic, Germany, Denmark, United Kingdom, Italy, Luxembourg, Netherlands, Sweden, Slovak Republic, South Africa, and Taiwan.

Code Information / Serial Numbers Lots # 58320651, 58320652, 58323511, 58323512, 58323513, 58326739, 58326740, 58326741, 58329130, and 58329131

Related Establishments / Registrations

Boston Scientific Corporation Registration: 1000121056 View Registration
C.R. BARD, INC. Registration: 1018233 View Registration
STERILIZATION SERVICES OF GEORGIA, INC. Registration: 1048735 View Registration
LEMAITRE VASCULAR, INC. Registration: 1220948 View Registration
NUMED, INC. Registration: 1318694 View Registration
Sterigenics U.S., LLC Registration: 1319639 View Registration
MEDICAL MURRAY, INC. Registration: 1424778 View Registration
Sterigenics U.S., LLC Registration: 1721676 View Registration
Terumo BCT STERILIZATION SERVICES, Inc. Registration: 1724474 View Registration
MIDWEST STERILIZATION CORP. Registration: 1928237 View Registration
Sterigenics US LLC Registration: 2011171 View Registration
EDWARDS LIFESCIENCES LLC Registration: 2015691 View Registration
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR Registration: 2029214 View Registration
LUCAS MEDICAL, INC. Registration: 2029386 View Registration
Isomedix Operations Inc. Registration: 2032112 View Registration
Boston Scientific Corporation Registration: 2124215 View Registration
Abbott Medical Registration: 2135147 View Registration
Isomedix Operations, Inc. Registration: 2183744 View Registration
TacPro, LLC dba Creganna Medical Registration: 2183982 View Registration
LYNX Medical Pennsylvania Registration: 2528981 View Registration
EDWARDS LIFESCIENCES TECHNOLOGY SARL Registration: 2648045 View Registration
Philips Electronics Ltd Registration: 3000126629 View Registration
Synergy Health Ireland Ltd Registration: 3002807314 View Registration
BOSTON SCIENTIFIC CORPORATION Registration: 3004859241 View Registration
ARROTEK MEDICAL LTD Registration: 3005255160 View Registration
Creagh Medical Ltd. Registration: 3005994106 View Registration
C.R. BARD, INC. Registration: 3006082230 View Registration
Abbott Medical Registration: 3007113487 View Registration
SPECTRANETICS CORP. Registration: 3007284006 View Registration
W. L. GORE & ASSOCIATES, INC. Registration: 3007284313 View Registration
Cerenovus, Inc. Registration: 3007628272 View Registration
MEDOS INTERNATIONAL SARL Registration: 3008114965 View Registration
I-Tek Medical, Inc. Registration: 3008627763 View Registration
F CARE SYSTEMS USA Registration: 3008816935 View Registration
STRYKER EMEA Supply Chain Services Registration: 3008837339 View Registration
Stryker Neurovascular Registration: 3008853977 View Registration
Stryker Neurovascular Registration: 3008881809 View Registration
ZIEN MEDICAL TECHNOLOGIES LLC Registration: 3009756153 View Registration
QXMEDICAL, LLC Registration: 3009766315 View Registration
MicroVention Costa Rica S.R.L. Registration: 3010079067 View Registration
Synergy Health Westport Ltd Registration: 3010173425 View Registration
Sterigenics Costa Rica S.R.L. Registration: 3010432890 View Registration
RENOVORX, INC. Registration: 3011279674 View Registration
EMBOLX INC. Registration: 3011660785 View Registration
BIOMERICS Advanced Catheter Registration: 3012159165 View Registration
St. Jude Medical Registration: 3012179728 View Registration
PRYTIME MEDICAL DEVICES, INC. Registration: 3012279212 View Registration
Stryker US Supply Chain Operations Registration: 3012497308 View Registration
MicroVention, Inc. Registration: 3013556777 View Registration
Eurofins Infinity Laboratory Group Inc. Registration: 3013944123 View Registration
BALT USA, LLC Registration: 3014162263 View Registration
Gore European Warehouse Support Registration: 3015138222 View Registration
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR Registration: 3015550451 View Registration
Philips Image Guided Therapy Corporation Registration: 3016257349 View Registration
CATHX MEDICAL INC Registration: 3016704395 View Registration
MIDWEST INTERVENTIONAL SYSTEMS Registration: 3016842760 View Registration
FRONT LINE MEDICAL TECHNOLOGIES INC. Registration: 3018565086 View Registration
Prytime Medical Devices, Inc. Registration: 3026788751 View Registration
BECTON, DICKINSON AND COMPANY Registration: 3032916632 View Registration
BALT EXTRUSION Registration: 8023054 View Registration
Boston Scientific Limited Registration: 9616684 View Registration
NUMED CANADA, INC. Registration: 9618000 View Registration
Boston Scientific Limited Registration: 9681260 View Registration

Public Record Disclaimer

This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Medical Device Recall: Z-0013-2009

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer