FDA recall Z-0120-2024

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/ GEN11 SW v2018-1 and Lower, REF HARH45R. surgical 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-0120-2024