Important Safety Alerts
Medical Device Safety Alert: Baxter Dual Luer Lock Caps
23 Sep 2013
The U.S. Food and Drug Administration (FDA) have posted a press release issued by Baxter concerning its Dual Luer Lock Caps with the followings:
- Product Code: 2C6250
- Lot number: 10043 and 10044
- Affected lots were distributed to customers between 19 Jun 2013 and 20 Aug 2013.
There is the presence of loose particulate matter found in the packaging of the affected products. Particulate matter entering the fluid path from the Luer Lock Caps may result in thrombotic and embolic events, including pulmonary embolism, myocardial infarction and stroke. There have been no reported complaints associated with this issue.
According to the manufacturer, customers should not use product from the two recalled lots and should locate and remove all affected product from their facility. Affected lots should be returned to Baxter.
According to the local supplier, the affected products were not distributed in Hong Kong.
For details, please refer to FDA website
http://www.fda.gov/Safety/Recalls/ucm369253.htm
If you are in possession of the product, please contact your supplier for necessary actions.
Posted on 23 September 2013