FDA-Device2025-04-02Class II
Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401904R, 401905R, 401933R, and 401991R
MEDLINE INDUSTRIES, LP - Northfield
Hazard
Devices may have higher than expected amounts of bacterial endotoxin.
Sold states
US Nationwide distribution in the states of AR, AZ, CA, CO, IA, IL, KS, OR, TN, TX, WA, and WI.
Affected count
74 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401904R, 401905R, 401933R, and 401991R
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1460-2025Don't want to check this manually?
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