Acacia Recalls Certain IV Extension Sets

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Acacia Inc. is recalling IV Extension Sets with BD Q-Syte Luer Access Device. Yesterday, Becton Dickinson & Co. pulled a multitude of BD Q-Syte Luer Access Devices and BD Nexiva Closed IV Catheter Systems because a device defect could cause an air embolism or leakage of blood or IV therapy, leading to severe injury or death.

The recall began on Oct. 28, 2009 after the company received complaints of air entry through a part of the device. Becton Dickinson & Co. is investigating reports of one death and one serious injury that could be associated

The Becton Dickinson recall involved 2.8 million BD Q-Syte Luer Access Device, as well as 2.9 million BD Nexiva units containing 5 million BD Q-Syte devices that were distributed in the United States, Asia, Canada, Europe, Mexico, the Middle East, South Africa and South America. Becton Dickinson & Co. is investigating reports of one death and one serious injury that may be linked to the recalled devices.

Becton’s call back notice said product failures occurred on lots of BD Q-Syte and BD Nexiva units distributed from November 2008 through November 2009. Becton Dickson said the main cause has been corrected and preventive measures are in place.

According to the Acacia Inc. recall notice, the following REF (catalog) and lot numbers, which were sold in the U.S., are included in its recall:

MPS Acacia IV Extension Set with BD Q-Syte REF:

385150, 385151,385164, 385165, 385166

Lot Numbers:

A1950, A1951, A1967, A1979, A2055, A2056, A2099, A2100, A2101, A2104

The approximately 217,000 recalled IV Extension Sets with BD Q-Syte were distributed in the United States exclusively to Becton Dickinson for delivery worldwide, including the United States, Canada, Europe, Asia, Australia, and North and South American Countries.

This recall was initiated on Dec. 18, 2009 after Acacia received information from Becton Dickinson of complaints regarding air entry through the bottom disk of the Q-Syte septum. Acacia has not received any customer notification of product failures with the Acacia IV Extension Sets with BD Q-Syte.

Acacia has notified the U.S. Food and Drug Administration and other necessary worldwide health agencies, and is working with them to coordinate recall activities. Clinicians or distributors with questions can contact Acacia at 1-800-486-6677 between 8:00 AM and 5:00 PM Pacific Standard Time, Monday-Friday, or dial directly at 714-257-0470.