FDA recall Z-3095-2024

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/GEN11 SW v2018-1 and Lower 5mm x 36cm. Item Number: HARH36R.

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-3095-2024