Enforcement Report - Week of February 6, 2013
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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. |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| 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. | 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. | Class II | 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. | 1253 units (962 units in the US & Puerto Rico) | Z-0757-2013 |
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