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U.S. Department of Health and Human Services

Class 2 Device Recall RX Accunet Embolic Protection System

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  Class 2 Device Recall RX Accunet Embolic Protection System see related information
Date Initiated by Firm November 30, 2011
Date Posted January 31, 2013
Recall Status1 Terminated 3 on January 31, 2013
Recall Number Z-0757-2013
Recall Event ID 60906
510(K)Number K081549  
Product Classification Temporary Carotid Catheter for Embolic Capture - Product Code NTE
Product Brand Name: RX Accunet Embolic Protection System
Common Name: RX Accunet EPS.

Part Numbers: 101649-45, 1011649-55, 1011649-65, 1011649-75, 1011650-55, 1011650-65, 1011651-45, 1011651-55.

The RX Accunet EPS is indicated for use as a guide wire and embolic protection system.
Code Information Lot Number: 1081061, 1082561, 1091361, 1080561, 1081761, 1090261, 1091561, 1100461, 1080361, 1081661, 1090161, 1090861, 1092361, 1080861, 1082661, 1100761, 1081761, 1092861, 1082461, 1081161, 1082261, 1083061, 1081961, 1093061.
Recalling Firm/
Manufacturer		 Abbott Vascular
26531 Ynez Rd
Temecula CA 92591-4630
For Additional Information Contact Elizabeth Boltz
951-914-3150
Manufacturer Reason
for Recall		 The recall was initiated because Abbot Vascular has discovered that the identified lots of the RX Accunet Embolic Protection System may exhibit difficult removal of the peel away sheath due to higher than normal wall thickness.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Abbott Vascular sent an "URGENT DEVICE RECALL" letter dated November 30, 2011 to all affected customers. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to work with their local account representative to review their inventory, complete the attached Field Action Reconciliation/ Effectiveness Check Form and return any unused identified products to Abbott Vascular.
Quantity in Commerce 1253 units (962 units in the US & Puerto Rico)
Distribution Worldwide Distribution-USA (nationwide) and the countries of Austria, Belgium, China, Germany, Spain, France, United Kingdom, Italy, Pakistan, Poland, Russia, Slovakia, Taiwan, and South Africa.
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 = NTE and Original Applicant = ABBOTT LABORATORIES
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