Recall Z-0910-2013 ยท DYB Introducer, Catheter
Bard Access Systems
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.
| Date | Mar 6, 2013 (initiated Feb 21, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Mixed-up of materials/components |
| Action | Bard sent an Urgent Recall Notification letters dated February 2013 to all affected customers. The letter identified the affected product, problem, and actions to be taken. Customers were instructed to examine their inventory for the affected product, return any remaining in stock and complete the enclosed Reply Form and Inventory Reconciliation Form. For questions contact Bard Access Systems Customer Service at 1-800-290-1689. |
| Quantity | 73 units |
| Distribution | USA Nationwide Distribution and the countries Europe, Belgium, Australia, and Latin America. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K830233 | NON-STERILE,SINGLE/SOUBLE LUMEN-CATH Evermed, Inc., Feb 28, 1983 |