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Recall Issued for Becton Dickinson IV Devices

Feb 9, 2010 | Parker Waichman LLP

Millions of  BD Q-Syte Luer Access Devices and BD Nexiva Closed IV Catheter Systems have been recalled by Becton Dickinson & Co. for a potentially lethal defect.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 United States, Asia, Canada, Europe, Mexico, the Middle East, South Africa and South America.

The recall was initiated on Oct. 28, 2009 after the company received complaints of problems due to air entry through a part of the device. According to the recall notice, the devices could cause an air embolism or leakage of blood or IV therapy, which could lead to serious injury or death. Becton Dickinson is investigating reports of one death and one serious injury that may be linked to the problem.

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 U.S., are also 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 U.S 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

According to the company’s recall notice, product failures occurred on lots of BD Q-Syte and BD Nexiva units distributed from November 2008 through November 2009. Becton Dickson said the root cause has been corrected and preventive measures, including additional inspections and preventive maintenance of the line, have been implemented.


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