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. This field corrective action included notification to customers worldwide by letter. Neither the costs anticipated with the recall, nor the impact on BD’s business, are expected to be material.
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 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
