FDA recall Z-0118-2024

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

MEDLINE ReNewal Ligasure Maryland Jaw Sealer/Divider Nano-Coated Complatible with FT10 Generator, REF LF1944CR. electrosurgical instrument

Reason for recall

Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.

Distribution

US

Key facts

Status: Ongoing
Initiation date: 2023-08-03
Report date: 2023-10-25
Voluntary/Mandated: Voluntary: Firm initiated
Location: Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0118-2024