Enforcement Report - Week of March 13, 2013
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Product Detail
| Product Description | 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. |
|---|---|
| Recall Number | Z-0910-2013 |
| Classification | Class II |
| Code Info | Lot numbers: HUWI1379 and HUWI1380. |
| Product Distributed Qty | 73 units |
| Reason For Recall | 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. |
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. |
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