FDA-Device2023-10-25Class II
MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/ GEN11 SW v2018-1 and Lower, REF HARH45R. surgical instrument.
MEDLINE INDUSTRIES, LP - Northfield
Hazard
Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.
Sold states
US
Affected count
18 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/ GEN11 SW v2018-1 and Lower, REF HARH45R. surgical instrument.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0120-2024Don't want to check this manually?
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