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Catheter Recall Expansion: Medline Industries Removes Reprocessed Electrophysiology and Ultrasound Catheters
The FDA is updating the communication "Catheter Recall: Medline Removes Certain Reprocessed Electrophysiology and Ultrasound Catheters" and issuing the new communication "Catheter Recall Expansion: Medline Removes Certain Reprocessed Electrophysiology and Ultrasound Catheters" to notify the public that Medline Industries has issued letters to affected customers recommending additional lots of reprocessed electrophysiology and ultrasound catheters be removed from where they are used or sold.
These updates are expansions of a previously communicated recall. Medline Industries recommends that customers take different actions based on the expansion in which the lot numbers were identified.
Product lots identified in the communication "Catheter Recall Expansion: Medline Removes Certain Reprocessed Electrophysiology and Ultrasound Catheters" should be destroyed after recall actions are complete.
Product lots identified in the communication "Catheter Recall: Medline Removes Certain Reprocessed Electrophysiology and Ultrasound Catheters" should be returned to Medline Industries.
Affected lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are 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.
This recall 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 recall should contact Medline Industries at recalls@medline.com or 866-359-1704.
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