藥 物 回 收
|
| |
| The United States: B. Braun issues voluntary nationwide recall of 0.9% Sodium Chloride for Injection USP 1000 mL in E3 containers due to the potential for particulate matter and leakage (English only) |
| |
The US Food and Drug Administration (FDA) announces that B. Braun Medical Inc. is voluntarily recalling two lots of 0.9% Sodium Chloride for Injection USP 1000 mL in E3 containers (lot number: J2L763, J2L764) within the United States to the consumer level. The voluntary recall has been initiated due to the potential for particulate matter and fluid leakage of the respective containers.
There is a reasonable probability of embolic phenomena such as stroke or ischemia/infarct to other organs and possible infection if these particulates are not sterile that could lead to permanent damage or impairment of body function which could be life-threatening.
The affected batches were inadvertently released to the market prior to the completion of the required acceptance activities for embedded particulate matter which may result in leakage. To date, there have been no customer complaints received and there have been no reports of serious injury or death associated with this issue.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/b-braun-issues-voluntary-nationwide-recall-09-sodium-chloride-injection-usp-1000-ml-e3-containers
In Hong Kong, Sodium Chloride Inj 0.9% (B Braun) (HK-28240), Sodium Chloride Inj 0.9% (B. Braun) (HK-44881) and Sodium Chloride Solution For Infusion 0.9% w/v (HK-66001) are pharmaceutical products registered by B. Braun Medical (HK) Ltd (B. Braun). All products are prescription-only medicines. As confirmed by B. Braun, the affected lots have not been imported into Hong Kong.
Ends/Friday, Aug 9, 2024
Issued at HKT 15:30
|
| |
|
