Becton, Dickinson & Co. 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 into the 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.
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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.
The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
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