FDA recall Z-1183-2025

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

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 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.

Distribution

US States: CA, NY

Key facts

Status: Ongoing
Initiation date: 2025-01-09
Report date: 2025-02-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1183-2025