Millions of Potentially Lethal IV Devices Recalled by Becton Dickinson
Date Published: Tuesday, February 9th, 2010
Becton Dickinson & Co. is recalling millions of BD Q-Syte Luer Access Devices and BD Nexiva Closed IV Catheter Systems. The recall was issued after determining that use of the devices could cause an air embolism or leakage of blood or IV therapy, which could lead to serious injury or death.
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. Becton Dickinson & Co. is investigating reports of one death and one serious injury that may be linked to the problem.
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.
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
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.
Becton Dickinson said it has notified the U.S. Food and Drug Administration and other worldwide health agencies, as necessary, and is working with them to coordinate recall activities.
This entry was posted
on Tuesday, February 9th, 2010 at 7:23 am and is filed under Defective Medical Devices, Product Recalls, Recalled Medical Devices.
Becton Dickinson & Co. is recalling millions of BD Q-Syte Luer Access Devices and BD Nexiva Closed IV Catheter Systems. The recall was issued after determining that use of the devices could cause an air embolism or leakage of blood or IV therapy, which could lead to serious injury or death.
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. Becton Dickinson & Co. is investigating reports of one death and one serious injury that may be linked to the problem.
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.
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
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.
Becton Dickinson said it has notified the U.S. Food and Drug Administration and other worldwide health agencies, as necessary, and is working with them to coordinate recall activities.
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