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FDA Gives Baxter Device Class I Status

Qmed Staff

September 20, 2013

1 Min Read
FDA Gives Baxter Device Class I Status

Following the discovery of loose particulate matter, Baxter International initiated a voluntary recall of its Dual Luer Lock Caps. Loose particulate matter can potentially enter the fluid path of the caps, resulting in thrombotic and embolic events like stroke, myocardial infarction and pulmonary embolism. Due to the life-threatening severity of this issue, FDA regulators designated this a Class I recall.

The company's Dual luer Lock Caps are used to protect the access ports on medical devices. This includes IV sets and stopcocks. While the devices are designed to prevent the entry of foreign matter, the contamination found in packaging for these devices could introduce adulterants into a patient's cardiovascular system.

According to Baxter, affected lots were distributed between June 19th of 2013 and August 20th of 2013. The company has requested customers to avoid the use of the recalled lots. This includes Product Code 2C6250, Lots 10043 and 10044. Lots not impacted by the recall are safe for continued use.

As of now, Baxter is providing credits for all affected lots. In its Class I notice, FDA regulators request that healthcare professionals and patients report all side effects or adverse events associated with the use of these products to the Adverse Event Reporting Program and the MedWatch Safety Information program.

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