PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: October 25, 2023 Initiated: August 3, 2023 #Z-0120-2024

Product Description

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.

Details

Units Affected
18 units
Distribution
US
Location
Northfield, IL

Frequently Asked Questions

What product was recalled?
MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/ GEN11 SW v2018-1 and Lower, REF HARH45R. surgical instrument.. Recalled by MEDLINE INDUSTRIES, LP - Northfield. Units affected: 18 units.
Why was this product recalled?
Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 25, 2023. Severity: Moderate. Recall number: Z-0120-2024.