FDA recall Z-3093-2024

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

Medline ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider, Nano-Coated, Compatible w/ FT10 37 cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF1937CR.

Reason for recall

Potential for an incomplete seal on the packaging tray.

Distribution

US Nationwide distribution.

Key facts

Status: Ongoing
Initiation date: 2024-05-07
Report date: 2024-09-18
Voluntary/Mandated: Voluntary: Firm initiated
Location: Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3093-2024