BD expands Class I IV recall

February 8, 2010 by MassDevice staff

Becton, Dickinson & Co. (NYSE:BDX) voluntarily expanded the Class I recall of millions of its Q-Syte Luer access devices to include its Nexiva intravenous catheter systems.

The recall, initiated last October, was prompted by complaints that air was introduced in to device through its septum's bottom disk, potentially leading to air embolisms or leakage that could cause serious injury or death. The Nexiva devices contain two of the Q-Syte components containing the defect, which was caused by a "manufacturing deviation," BD said.

The defect occurred in about 2.8 million BD Q-Syte and 2.9 million BD Nexiva units containing 5 million BD Q-Syte devices distributed from November 2008 to November 2009 in the U.S., Asia, Canada, Europe, Mexico, the Middle East, South Africa and South America. BD said it corrected the problem and expects the recall to have a negligible effect on its books.

The recall affects the following catalog and lot numbers:

• BD Q-Syte sold in the U.S., catalog nos. 385100, 385101, 385102, 385108, 385150, 385151, 385164;
• BD Q-Syte sold in the U.S., lot nos. 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;
• BD Q-Syte sold outside the U.S., catalog nos. 380510, 385100, 385101;
• BD Q-Syte sold outside the U.S., lot nos. 8310565, 8331938, 8331946, 9007907, 9008474, 9028892;
• BD Nexiva sold in the U.S. and internationally, catalog nos. 383530, 383531, 383532, 383533, 383534, 383536, 383537, 383538, 383539, 383540, 383647, 383649
• BD Nexiva sold in the U.S. and internationally, lot nos. 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.

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