MB: Here's an alert about certain lots of Q-Syte Luer access devices. These are split-septum needleless valves that are used with other infusion therapy products to administer IV fluids. The Q-Syte devices are sold by themselves and also, they're sometimes packaged with other devices as parts of systems or kits, including certain IV and central venous catheter sets.
AR: Becton Dickinson, the manufacturer of the Q-Syte device, is recalling certain lots because of complaints of air entering through the bottom disk of the device's septum. Using the recalled devices may cause an air embolism or may cause blood or therapy fluids to leak, which could result in serious injury or death. After investigating the complaints, the company determined that a manufacturing deviation was the cause of the problem.
MB: The company says that the recalled Q-Syte devices were distributed worldwide from November 2008 through November 2009. Certain catalog and lot numbers of the following kits and systems are also being recalled because they contain the affected Q-Syte devices. To date, these include:
• Nexiva Closed IV Catheter Systems sold by BD;
• IV Extension Sets sold by Acacia Inc.;
• Central Venous Catheter Kits sold by Arrow International; and,
• IV kits sold by Medical Action Industries.
AR: Several million units are affected. Anyone who has the affected devices should not use them, remove them from inventory and contact the company. You can get more information on the specific catalog numbers and lot numbers for the recalled products on our website. We'll update the site as additional information becomes available.
标题
Q-Syte Luer Access Devices Recalled (FDA)
视频介绍
FDA Patient Safety News - April, 2010 - Show #97
Certain lots of Q-Syte Luer access devices, which are used to administer IV fluids, are being recalled because air may enter through the bottom disk of the device's septum.
Speaker #1: Mark Barnett (MB), Assistant Director, Education & Communication, U.S. Food and Drug Administration
Speaker #2: Anita Rayner (AR), Associate Director, Policy & Communications, U.S. Food and Drug Administration
