FDA-Device2025-10-08Class I
Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping of cardiac structures. Medline Item Numbers BD710DF282CRH BD710DF282RRH BD710FJ282CRH BD710FJ282RRH
Medline Industries, LP
Hazard
Specific 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.
Sold states
Domestic US distribution nationwide. International distribution pending. No international distribution.
Affected count
7913 eaches
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping of cardiac structures. Medline Item Numbers BD710DF282CRH BD710DF282RRH BD710FJ282CRH BD710FJ282RRH
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2611-2025Don't want to check this manually?
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