FDA-Device2025-04-16Class II
MEDLINE ReNewal Coblator II ENT Evac 70 Xtra HP,w/Integrated Cable (Blue/Grey), Number REF EICA58740R
MEDLINE INDUSTRIES, LP - Northfield
Hazard
Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
Sold states
US Nationwide distribution
Affected count
020 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
MEDLINE ReNewal Coblator II ENT Evac 70 Xtra HP,w/Integrated Cable (Blue/Grey), Number REF EICA58740R
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1547-2025Don't want to check this manually?
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