FDA Enforcement
Class II
Ongoing
Medline convenience kits: ADD-A-CATH ARTERIAL INSERTION ARTNC185 PED SCHOOL AGE PICC DRSG TRAY DYNDC3291
Recall: Z-2445-2026
·
Reported June 24, 2026
Enforcement
- Recall Number
- Z-2445-2026
- Event ID
- 98951
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Medline Industries, LP
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- June 24, 2026
- Initiation Date
- April 27, 2026
- Classification Date
- June 12, 2026
- Address
- 3 Lakes Dr, Northfield, IL, 60093-2753, United States
Description
Medline convenience kits: ADD-A-CATH ARTERIAL INSERTION ARTNC185 PED SCHOOL AGE PICC DRSG TRAY DYNDC3291
Reason
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Code Info
ARTNC185 UDI-DI 10195327640729 Lot 25JBU463 DYNDC3291 UDI-DI 10195327334741 Lot 25KBH082
Distribution
US Nationwide distribution. OUS distribution pending.
Quantity
49,654 kits total