Z-0120-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 25, 2023
- Initiation Date
- August 3, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18 units
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.
Distribution Pattern
US
Code Information
UDI/DI 10193489081336 (each), 20193489081333 (case), Lot Numbers: 498739, 498740, 499057, 499143, 499227