Intravenous products: BD 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-Syteâ„¢ 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 Oct. 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 Oct. 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
Patient safety and the quality and safety of our products are BD’s first priorities. The recall was initiated on Oct. 28, 2009 after BD received complaints due to air entry through the bottom disk of the septum. BD investigated and determined the root cause to be a manufacturing deviation. Product failures occurred on lots of BD Q-Syte and BD Nexiva units distributed from November 2008 through November 2009. The root cause has been corrected and preventive measures, including additional inspections and preventive maintenance of the line, have been implemented.
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.
BD 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. Clinicians or distributors with questions can contact BD at 1-800-453-4538, option 2, extension 2585, between 8:00 AM and 5:00 PM Mountain Standard Time, Monday-Friday, or dial directly at 1-801-565-2300, x2585 or x2860.
Adverse reactions or quality problems experienced with the use of this product may be reported to FDA’s MedWatch Adverse Event Reporting program either on line, by regular mail or by fax:
Online: www.fda.gov/medwatch/report.htm
Regular mail: Use postage-paid FDA form 3500 available at: www.fda.gov/medwatch/getforms.htm Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
Fax: 1-800-FDA-0178