FDA-Device2024-09-18Class II

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.

MEDLINE INDUSTRIES, LP - Northfield
Hazard

Potential for an incomplete seal on the packaging tray.

Sold states
US Nationwide distribution.
Affected count
46 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3095-2024

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