Recall Z-3095-2024— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-3095-2024
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: K193563. Product: Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/GEN11 SW v2018-1 and Lower 5mm x 36cm. Item Number: HARH36R.. 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

K193563 — Medline ReNewal Reprocessed Harmonic ACE+7 ShearsSurgical Instrument Service and Savings Inc.(Dba Medline Ren·cleared 2020-08-19

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 Ethicon Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/GEN11 SW v2018-1 and Lower 5mm x 36cm. Item Number: HARH36R.

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.