Reported Mar 13, 2013 · Terminated
Leonard 10.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer…
Bard Access Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bard Access Systems · 605 North 5600 West · Salt Lake City, UT · 84116-3738
Is this the product you have?
- Leonard 10.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (product code 0600630)
- Product UsageHickman and Leonard Catheters are designed for long-term vascular access and for use in patients that lack adequate peripheral venous access
- Lot codes and dates
- Lot numbersHUWI1379 and HUWI1380
- Amount recalled
- 73 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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