Recall Z-3092-2024— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-3092-2024
Creator: U.S. Food and Drug Administration
Published: 2024-05-07

Class II · Ongoing

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2024-05-07. It names one FDA 510(k) clearance: K160333. Product: Medline ReNewal Reprocessed Covidien LigaSure Blunt Tip, Sealer/Divider, Nano-Coated, Compatible w/ FT10 37cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF1837CR.. Reason: Potential for an incomplete seal on the packaging tray..

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Classification: Class II
Status: Ongoing
Initiated: 2024-05-07
Firm location: Northfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K160333 — Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/DividerSurgical Instrument Service and Savings, Inc.·cleared 2016-07-20

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 Reprocessed Covidien LigaSure Blunt Tip, Sealer/Divider, Nano-Coated, Compatible w/ FT10 37cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF1837CR.

Reason for recall

Potential for an incomplete seal on the packaging tray.

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