Medical device recalls Moderate risk

MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE ReNewal ENT Coblator II PROcise XP Wand,w/Integrated Cable Suction & Saline (Blue), Item Number REF EICA88720R

Recall date
March 5, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1548-2025
FDA classification
Class II
Brand / firm
MEDLINE INDUSTRIES, LP - Northfield
Sold / distributed
US Nationwide distribution

Why it was recalled

Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MEDLINE ReNewal ENT Coblator II PROcise XP Wand,w/Integrated Cable Suction & Saline (Blue), Item Number REF EICA88720R

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