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BD Recalls Q-Syte Luer Access Devices, Nexiva Closed IV Catheter Systems

BD (Becton, Dickinson and Company) has voluntarily executed a product recall of certain lots of BD Q-Syte Luer Access Devices and BD Nexiva Closed IV Catheter Systems. Use of the affected devices may cause an air embolism or leakage of blood and/or therapy, which may result in serious injury or death.

The BD Q-Syte Luer Access device is intended for use with other infusion therapy products in the administration of fluids into the intravenous system. BD Nexiva has been added to the scope of this recall that was first initiated on October 28, 2009. The BD Nexiva product has two BD Q-Syte devices within the package that could potentially be subject to the manufacturing deviation previously referenced in the October 28, 2009 recall letter.

The REF (catalog) and lot numbers of BD Q-Syte, which were sold in the US and included in the recall are REF- 385100, 385101, 385102, 385108, 385150, 385151, 385164 and the lot numbers include 8268863, 8269020, 8275798, 8305510, 8305511, 8308321, 8308323, 8308330, 8309553, 8331937, 8331940, 8331944, 8354558, 8354561, 9007921, 9009643, 9009646, 9028838, 9035029, 9035032, 9012072, 9007918, 9035042, 9035044, A1967, A1979, A2056, A1950, A2399, A1951.

The REF and lot numbers, which were sold outside of the US, also included in the recall are BD Q-Syte REF- 380510, 385100, 385101 and with lot numbers 8310565, 8331938, 8331946, 9007907, 9008474, 9028892.

The REF and lot numbers of BD Nexiva which were sold in the US and internationally that are included in the recall are BD Nexiva REF- 383530, 383531, 383532, 383533, 383534, 383536, 383537, 383538, 383539, 383540, 383647, 383649 and the lot numbers are 8238450, 8248349, 8248355, 8249034, 8249035, 8259950, 8263293, 8263294, 8269338, 8270576, 8270579, 8274555, 8274565, 8275207, 8275210, 8275429, 8283964, 8284049, 8284050, 8290311, 8291980, 8295761, 8296792, 8296793, 8305438, 8308349, 8309299, 309662, 8311150, 8311167, 8312211, 8312220, 8319016, 8319936, 8319961, 8322609, 8330279, 8331763, 8331771, 8338737, 8338738, 8340302, 8340308, 8345951, 8345957, 8347056, 8347058, 8358628, 9007360, 9013864, 9013867, 9013868, 9015539, 9016819, 9020033, 9022039, 9026722, 9034319, 9041552.

The company said that the recall was initiated on October 28, 2009 after BD received complaints due to air entry through the bottom disk of the septum. BD investigated and determined the root cause to be a manufacturing deviation. Product failures had occurred on lots of BD Q-Syte and BD Nexiva units which were distributed from November 2008 through November 2009. The root cause has been corrected and preventive measures, including additional inspections and preventive maintenance of the line, have been implemented.

The approximately 2.8 million BD Q-Syte and 2.9 million BD Nexiva units containing 5 million BD Q-Syte devices that were recalled were distributed in the US, Asia, Canada, Europe, Mexico, the Middle East, South Africa and South America.

BD has notified the FDA and other worldwide health agencies, as necessary, and is working with them to coordinate recall activities.