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U.S. Department of Health and Human Services

Class 2 Device Recall Edwards Lifesciences Suction Wand Model S099B

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 Class 2 Recall
Edwards Lifesciences Suction Wand Model S099B
see related information
Date Posted August 20, 2013
Recall Status1 Terminated on January 28, 2014
Recall Number Z-1985-2013
Recall Event ID 65869
Premarket Notification
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, Colorado 80004-3503
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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DWF and Original Applicant = COBE LABORATORIES, INC.
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