Edwards Lifesciences LLC, EMBOL-X Glide Protection System
Date Recall Initiated: Sept. 16, 2013
Product: EMBOL-X Glide Protection System
Model Numbers: EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD, EXGF24XLD, EXGF24XSD, EXGFXS2D, EXGF24SS2D, EXGF24MM2D, EXGF24LL2D and EXGF24XL2D
Edwards Lifesciences is recalling all lot numbers of the EMBOL-X Glide Protection System Cannulae that have not expired.
To locate the part number with the lots involved in the recall, refer to the firm’s Urgent Field Safety Notice under Additional Links below.
The EMBOL-X Glide Protection System was manufactured From Sept. 21, 2010 through July 12, 2013 and distributed from Sept. 21, 2010 through Aug. 22, 2013.
Use: The EMBOL-X access device system can help capture material such as blood clots or tissue fragments during short-term (equal to or less than 6 hours) cardiopulmonary bypass surgery when surgeons may need to introduce and remove devices into the vascular system.
Recalling Firm:
Edwards Lifesciences, LLC
12050 Lone Peak Parkway
Draper, Utah, 84020
Reason for Recall: The tip of the catheter is being recalled due to a deformed cannula tip. Use of this recalled product may cause serious adverse health consequences, including death.
Public Contact:
Customers affected by this recall may contact Edwards Customer Service at 800-424-3278 from 6:00 AM – 4:30 PM Pacific Standard Time or contact your Edwards' sales representative concerning this recall.
FDA District: Denver District Office
FDA Comments:
On Sept. 16, 2013 the firm sent their customers an Urgent Field Safety Notice. The firm asked their customers who received one or more of the affected lots to take the following actions:
Review your entire inventory of the cannulae listed in the safety notice.
Immediately quarantine affected material at your site and return this product to Edwards.
If you have additional inventory within your control, please add the lot number and quantity to the section on the form provided.
Remove the cannulae from any kits you have received, quarantine the affected material at your site, and return this product to Edwards.
The filter is not affected and does not have to be returned with the cannulae.
An acknowledgment form is included to assist you in the assessment of your inventory.
Once you have verified your inventory, please complete the attached acknowledgment form and fax it back to Edwards Customer Service at 800-422-9329 within three days of receipt of this Field Safety Notice. The return of this form allows Edwards to confirm that you have reviewed the notice and have taken appropriate action.
Please contact Customer Service at 800-424-3278 to obtain a Returned Goods Authorization number and replacement product.
Return the affected product to:
Edwards Lifesciences
Attn: Santosh Bhagat
12050 Lone Peak Drive
Draper, UT 84020
Attention: RECALL: RGA#XXXXXX
For questions that have not been answered by the letter, please call Edwards Customer Service at 800-424-3278 from 6:00 AM – 4:30 PM Pacific Standard Time or contact your Edwards sales representative concerning this recall.
Transmission of this Field Safety Notice:
This notice needs to be passed on to all those within your organization or to any organization where the potentially affected devices have been transferred. Please transfer this notice to other organizations on which this action has an impact.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.
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