Recall Z-0711-2024— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-0711-2024
Creator: U.S. Food and Drug Administration
Published: 2023-11-29

Class II · Ongoing

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2023-11-29. It names one FDA 510(k) clearance: K182172. Product: Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile.. Reason: Surgical gowns were manufactured with the wrong sleeve..

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Classification: Class II
Status: Ongoing
Initiated: 2023-11-29
Firm location: Northfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K182172 — Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora)Medline Industries, Inc.·cleared 2019-04-24

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 Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile.

Reason for recall

Surgical gowns were manufactured with the wrong sleeve.

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