Date Initiated by Firm |
July 08, 2013 |
Date Posted |
August 20, 2013 |
Recall Status1 |
Terminated 3 on January 28, 2014 |
Recall Number |
Z-1985-2013 |
Recall Event ID |
65869 |
510(K)Number |
K881330
|
Product Classification |
Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
|
Product |
Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs. |
Code Information |
Model S099B |
Recalling Firm/ Manufacturer |
Sorin Group USA, Inc. 14401 W 65th Way Arvada CO 80004-3503
|
For Additional Information Contact |
303-467-6306
|
Manufacturer Reason for Recall |
Sorin Group is recalling certain lots of Edwards Lifesciences Suction Wand Model S099B due to presence of plastic particles inside the pouch.
|
FDA Determined Cause 2 |
Material/Component Contamination |
Action |
On 7/8/13, customers and distributors were sent a "Field Safety Notice Product Recall" letter and requested to return unused Edwards Suction Wands found in the Perfusion Packs to the Sorin Group. Customers are to contact Sorin Group Customer Service at 1-800-650-6502 to receive instructions for returning the affected Edwards Suction Wand to Sorin. Customers were also advised to not discard affected product. |
Quantity in Commerce |
18,927 packs |
Distribution |
Nationwide Distribution |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = DWF and Original Applicant = COBE LABORATORIES, INC.
|