Acacia (MPS Acacia) has voluntarily executed a product recall of certain lots of IV Extension Sets with BD Q-Syte Luer Access Device. The recall has been initiated on December 18, 2009 after Acacia has received information from BD of complaints received due to air entry through the bottom disk of the Q-Syte septum.
The BD Q-Syte Luer Access Device is a needleless valve manufactured by BD (Becton, Dickinson and Company). Use of the affected BD Q-Syte Luer Access Device may cause an air embolism or leakage of blood and/or therapy, which may result in serious injury or death. This field corrective action has been included notification to customers worldwide by letter.
Acacia said that IV Extension Set with BD Q-Syte Luer Access device is intended for use with other infusion therapy products in the administration of fluids into the intravenous system.
The REF (catalog) and lot numbers, which were sold in the US, included in the recall are MPS Acacia IV Extension Set with BD Q-Syte REF: 385150, 385151, 385164, 385165, 385166. Lot numbers include A1950, A1951, A1967, A1979, A2055, A2056, A2099, A2100, A2101, A2104.
BD had investigated and determined the root cause to be a manufacturing deviation. Though Acacia has not received any customer notification of product failures with the Acacia IV Extension Sets with BD Q-Syte, product failures occurred with BD labeled devices that included BD Q-Syte units distributed from November 2008 through November 2009. The root cause has been corrected by BD and preventive measures, including additional inspections and preventive maintenance of the line, have been implemented.
The approximately 217,000 IV Extension Sets with BD Q-Syte that were recalled were distributed in the US to BD for distribution worldwide, which includes the US, Canada, Europe, Asia, Australia, and North and South American countries.