September 17 , 2007

FDA ALERT

 

FDA MedWatch: Normal Saline Flush Syringes Manufactured By B. Braun Medical Inc. Recalled Due To Presence Of Medical Grade Silicone

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

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 sever 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.

Read the complete MedWatch 2007 Safety Summary including a link to the Dear Doctor and Dear Healthcare Professional Letters and Prescribing information, at:

http://www.fda.gov/medwatch/safety/2007/safety07.htm#SalineFlush