Z-0117-2024 Class II Ongoing
FDA device recall Z-0117-2024 was initiated by MEDLINE INDUSTRIES, LP - Northfield on August 3, 2023 and is designated Class II. Reason for recall: Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray. The recall status is ongoing. Affected quantity: 11 units.
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
- 11 units
Product Description
MEDLINE ReNewal Ligasure Blunt Tip Sealer/Divider Nano-Coated Compatible with FT10 Generator, REF LF1844CR. electrosurgical 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 10888277680418 (each), 20888277680415 (case), Lot Numbers: 498004