Z-3094-2024 Class II Ongoing
FDA device recall Z-3094-2024 was initiated by MEDLINE INDUSTRIES, LP - Northfield on May 7, 2024 and is designated Class II. Reason for recall: Potential for an incomplete seal on the packaging tray. The recall status is ongoing. Affected quantity: 230 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 18, 2024
- Initiation Date
- May 7, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 230 units
Product Description
Medline ReNewal Reprocessed Covidien LigaSure Impact, Sealer/Divider, Nano-Coated, Compatible w/ FT10 18cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF4418CR.
Reason for Recall
Potential for an incomplete seal on the packaging tray.
Distribution Pattern
US Nationwide distribution.
Code Information
Item Number: LF4418CR. UDI/DI: 20888277680446 (case), 10888277680449 (each). Lot Numbers: 500376, 500379, 500380, 500381, 500382, 500504, 500506, 500548, 500559, 500652, 500695, 500874, 503004, 503289.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3094-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026