Enforcement Report - Week of March 13, 2013
-
Back to Previous Page
Event Detail
| Event ID | 64425 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Bard Access Systems |
| City | Salt Lake City |
| State | UT |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2013-02-21 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | USA Nationwide Distribution and the countries Europe, Belgium, Australia, and Latin America. |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Hickman 9.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (pediatric product code 0600580; adult product code 0600600). Product Usage: Hickman and Leonard Catheters are designed for long-term vascular access and for use in patients that lack adequate peripheral venous access. | Lot numbers: HUWI1379 and HUWI1380. | Class II | Bard Access Systems is recalling two lots of Hickman 9.0 French and one lot of Leonard 10.0 French Dual Lumen Catheters with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer Systems due to the wrong size introducer being included with the kit. | 195 units. | Z-0909-2013 |
| Leonard 10.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (product code 0600630). Product Usage: Hickman and Leonard Catheters are designed for long-term vascular access and for use in patients that lack adequate peripheral venous access. | Lot numbers: HUWI1379 and HUWI1380. | Class II | Bard Access Systems is recalling two lots of Hickman 9.0 French and one lot of Leonard 10.0 French Dual Lumen Catheters with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer Systems due to the wrong size introducer being included with the kit. | 73 units | Z-0910-2013 |
-
