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Becton, Dickinson and Company Issues Recall

Affects certain lots of BD Q-Syte Luer Access Devices and BD Nexiva Closed IV Catheter Systems.

By: Tim Sohn

Associate Editor

Becton, Dickinson and Company (BD) has voluntarily recalled certain lots of BD Q-Syte Luer Access Devices and BD Nexiva Closed IV Catheter Systems. Notification was distributed to customers worldwide by letter, according to the Franklin Lakes, N.J., medical device manufacturer.

BD Nexiva has been added to the scope of this recall, which was first initiated on Oct. 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 Oct. 28, 2009 recall letter. 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.

The following REF (catalog) and lot numbers, which were sold in the U.S., are included in the recall:

BD Q-Syte REF: 385100, 385101, 385102, 385108, 385150, 385151, 385164

Lot Numbers: 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 following REF and lot numbers, which were sold outside of the United States, also are included in the recall:

BD Q-Syte REF: 380510, 385100, 385101

Lot Numbers: 8310565, 8331938, 8331946, 9007907, 9008474, 9028892

The following REF (catalog) and lot numbers of BD Nexiva were sold in the United States and internationally and are included in the recall:

BD Nexiva REF: 383530, 383531, 383532, 383533, 383534, 383536, 383537, 383538, 383539, 383540, 383647, 383649

Lot Numbers: 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 recall was initiated on Oct. 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 occurred on lots of BD Q-Syte and BD Nexiva units 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, according to BD.

Adverse reactions quality problems may be reported to FDA’s MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm.

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