FDA recall Z-1549-2025

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

MEDLINE ReNewal ENT Coblator II PROcise mAx,W/ Integrated Cable Suction & Saline (Blue), Item Number REF EICA88980R

Reason for recall

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

Distribution

US Nationwide distribution

Key facts

Status
Ongoing
Initiation date
2025-03-05
Report date
2025-04-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1549-2025