Recall Z-0119-2024— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-0119-2024
Creator: U.S. Food and Drug Administration
Published: 2023-08-03

Class II · Ongoing

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2023-08-03. It names one FDA 510(k) clearance: K153745. Product: MEDLINE ReNewal Ligasure Sealer/Divider Nano-Coated Compatible with FT10 Generator, REF LF4418CR. electrosurgical instrument. Reason: Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray..

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Classification: Class II
Status: Ongoing
Initiated: 2023-08-03
Firm location: Northfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K153745 — Medline ReNewal Reprocessed LigaSure Impact Open Sealer/DividerSurgical Instrument Service and Savings Inc.(Dba Medline Ren·cleared 2016-05-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

MEDLINE ReNewal Ligasure Sealer/Divider Nano-Coated Compatible with FT10 Generator, REF LF4418CR. electrosurgical instrument

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.