Medline medical procedure convenience kits labeled as: 1) INPATIENT CTRL LN DRG CHG, Kit SKU D...
FDA Recall #Z-1195-2026 — Class II — December 12, 2025
Product Description
Medline medical procedure convenience kits labeled as: 1) INPATIENT CTRL LN DRG CHG, Kit SKU DT22880; 2) ADULT CVC DRSG CHG W/ADHESIVE, Kit SKU DYNDC3283A.
Reason for Recall
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
Recalling Firm
Medline Industries, LP — Northfield, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1,928 total
Distribution
US Nationwide distribution.
Code Information
Medline Kit SKU DT22880: UDI/DI 10653160995470 (EA) 40653160995471 (CS), Lot Number 25KMJ441; Medline Kit SKU DYNDC3283A: UDI/DI 10198459313240 (EA) 40198459313241 (CS), Lot Number 25KMH515.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated