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U.S. Department of Health and Human Services

Enforcement Report - Week of February 6, 2013

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Product Detail

Product Description 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.
Recall Number Z-0757-2013
Classification Class II
Code Info 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.
Product Distributed Qty 1253 units (962 units in the US & Puerto Rico)
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.

Event Detail

Event Id 60906
Product Type Devices
Status Terminated
Recalling Firm Abbott Vascular
City Temecula
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-11-30
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern 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.
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