Normal Saline Flush Syringes Manufactured By B. Braun Medical Inc. Recalled Due To Presence Of Medical Grade Silicone
2007-09-17
September 15, 2007, the US Food and drug Administration, the American's equivalent to the Saudi Food and Drug Authority (SFDA), announced important safety information regarding Normal Saline Flush Syringes
B. Braun Medical Inc., issued a recall of Normal Saline Flush Syringes with lot numbers ending in "SFR" due to an increase in customer complaints of particulate matter in the saline. The introduction of particular matter into the blood stream may result in phlebitis and/or damage to vital organs such as the brain, kidneys, heart and lungs. To a less likely extent, there is also a potential for the development of pulmonary embolism or silicone embolism syndrome, which could cause severe injury and/or death. To date, B. Braun has received no reports of any patient injury associated with this issue.
Customers that have the recalled product in their possession should discontinue use immediately and contact their physician if they have experienced any problems that may be related to the usage of this product.
Report Adverse Drug Reactions to the Saudi FDA:
The public and health professionals are encouraged to report adverse drug reactions to the National Pharmacovigilance Center on the Internet at :
http://www.sfda.gov.sa/En/Drug/Topics/Pharmacovigilance_Center.htm