FDAFDA · Food and drugs·Recall number Z-0910-2013
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.
Published March 13, 2013 · Recall initiated: February 21, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Bard Access Systems
- Distributor
- USA Nationwide Distribution and the countries Europe, Belgium, Australia, and Latin America.
- Lot
- Lot numbers: HUWI1379 and HUWI1380.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.