FDAClass IIOctober 25, 2023

MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. recall

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

Why was MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. recalled?

Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI/DI 10193489081336 (each), 20193489081333 (case), Lot Numbers: 498739, 498740, 499057, 499143, 499227

Product
MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/ GEN11 SW v2018-1 and Lower, REF HARH45R. surgical instrument.
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
18 units
Distribution
US
Recall date
October 25, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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