Acacia Inc. Recalls IV Extension Sets with BD Q-Syte Luer Access DeviceFeb 10, 2010 | Parker Waichman LLP
Acacia Inc. is recalling IV Extension Sets with BD Q-Syte Luer Access Device. As we reported yesterday, the BD Q-Syte Luer Access Device was recalled by Becton Dickinson & Co. because of a defect that could cause an air embolism or leakage of blood or IV therapy, which may result in serious injury or death.
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. Product failures occurred on lots of BD Q-Syte and BD Nexiva units distributed from November 2008 through November 2009, Becton Dickinson said.
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
A1950, A1951, A1967, A1979, A2055, A2056, A2099, A2100, A2101, A2104
The approximately 217,000 IV Extension Sets with BD Q-Syte that were recalled were distributed in the United States exclusively to Becton Dickinson for distribution worldwide, which includes 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 received due to 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.
Becton Dickinson investigated and determined the root cause to be a manufacturing deviation . The root cause has been corrected by Becton Dickenson and preventive measures, including additional inspections and preventive maintenance of the line, have been implemented, the recall notice said.
Acacia has notified the U.S. Food and Drug Administration and other worldwide health agencies, as necessary, 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.