Q-Syte Luer Access Device Recall Expanded: Air Leakage May Cause Death

Defective manufacturing that caused an infant to suffer an air embolism has resulted in the expansion of a Class 1 medical recall for millions of Q-Syte Luer Access devices, which are used to add drug therapies to intravenous systems. 

The FDA notified health care professionals of the Q-Syte Luer Access recall expansion this week. The device, manufactured by Becton, Dickinson and Company (BD) was sold separately and as a part of millions of medical infusion sets. The company notified the FDA that they received reports that a manufacturing problem could cause air to leak into the device, which has led to at least one French infant suffering an air embolism.

The original recall for the Q-Syte Luer Access device affected about 7.8 million units sold with BD Q-Syte Luer Access Devices and BD Nexiva Closed IV Catheter Systems. The expanded recall includes dozens more lots and other medical infusion systems that also include the defective Q-Syte Luer devices.

The FDA has classified the action as a Class 1 Medical Device recall, meaning use of the devices could lead to serious injury or death.

The Q-Syte Luer Access is a needleless valve device that is used to add drugs and therapies, like chemotherapy, blood and fluids, to infusion systems that are providing intravenous feeds to patients. The bottom disc of the septum was cut incorrectly on millions of these devices, allowing air to infiltrate the system.

BD announced in a recent press release that the manufacturing problem has been fixed and additional inspection measures have been added to prevent similar problems in the future.

According to the FDA, the defective Q-Syte Luer Access devices could allow air to leak into a patient’s bloodstream and cause an air embolism. The problem can also cause infusion therapy fluids and blood to leak. Complications that could arise from the defective devices include:

• Hypotension
• Hemodynamic instability
• Requirement for additional blood transfusions
• Blood-borne hospital infections
• Serious patient injury or death

The recall has been expanded to include MPC Acacia IV Extension Sets, Medical Action Industries IV start, venous access trays and dialysis kits, Arrow International central venous access kits and sheath introducer kits. A complete list of the lot numbers of affected devices is available at the bottom of the FDA’s recall notice.

The devices were sold worldwide.

The FDA is recommending that health care professionals check the lot numbers on the product packaging to determine if they are using devices affected by the recall. Health care professionals should not use any devices affected by the recall, because the defect cannot be visually detected. If they are unsure whether a device is affected by the recall, they should not use it.

The FDA also recommends that all medical facilities and distributors perform an inventory inspection for the recalled devices, and also suggest patients receiving treatments at home who suspect they are using Q-Syte Luer Access devices immediately contact their home health provider or medical supplies provider.