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The U.S. Food and Drug Administration (FDA) has updated the “Catheter Recall Expansion: Medline Industries Removes Reprocessed Electrophysiology and Ultrasound Catheters” recall communication as Medline Industries has added to the list of affected lots for this recall. The recommendations provided for the recall have not changed.
In a December 22 letter to affected customers, Medline stated that specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If an affected catheter is used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.
As of June 16, Medline has not reported any serious injuries or deaths related to this issue.
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Medline Industries at recalls@medline.com or call 1-866-359-1704.
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