icon
沙特阿拉伯王国政府所属的官方政府网站。
icon 周四 25 6月 2026
icon
沙特官方政府网站的域名以下列后缀结尾 gov.sa

沙特阿拉伯王国所有政府机构的官方网站均以 .gov.sa 结尾。

icon
政府网站使用以下协议。 HTTPS 用于加密和安全。

沙特阿拉伯王国所有政府机构的官方网站均以 .gov.sa 结尾。

icon
在数字政府管理局注册,编号:
20250831619
建议

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

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

icon 2024-02-21

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

 
icon

Warning date

2007-09-17