Recall Z-1183-2025— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-1183-2025
Creator: U.S. Food and Drug Administration
Published: 2025-01-09

Class II · Ongoing

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2025-01-09. It names one FDA 510(k) clearance: K213481. Product: Medline Convenience Kits for Various Procedures: 1) CLOVIS RESP/INTUB DRAWER 2, Model Number ACC010809; 2) RESP/INTUBATION DRAWER #2, Model Number ACC010813. Reason: Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to a shorter duration that a skin barrier can effectively adhere to and protect the skin before it needs to be replaced..

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Classification: Class II
Status: Ongoing
Initiated: 2025-01-09
Firm location: Northfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K213481 — Medline General Surgery TrayMedline Industries, Inc.·cleared 2022-05-24

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 Convenience Kits for Various Procedures: 1) CLOVIS RESP/INTUB DRAWER 2, Model Number ACC010809; 2) RESP/INTUBATION DRAWER #2, Model Number ACC010813

Reason for recall

Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to a shorter duration that a skin barrier can effectively adhere to and protect the skin before it needs to be replaced.

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