FDA Enforcement
Class II
Ongoing
Medline convenience kits: INPATIENT CENTRAL LN DRSG KIT DYNDC3525 PICC/CVC/MIDLINE DRSG CHG KIT DT13191A PORT A CATH CDS982047S VEIN ABLATION PACK DYNJ62889C
Recall: Z-2419-2026
·
Reported June 24, 2026
Enforcement
- Recall Number
- Z-2419-2026
- 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: INPATIENT CENTRAL LN DRSG KIT DYNDC3525 PICC/CVC/MIDLINE DRSG CHG KIT DT13191A PORT A CATH CDS982047S VEIN ABLATION PACK DYNJ62889C
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
DYNDC3525 UDI-DI 10198459576294 Lot 25KBM985 DT13191A UDI-DI 10653160998914 Lot 26AMA168 CDS982047S UDI-DI 10198459385735 Lot 26AMB202 DYNJ62889C UDI-DI 10198459416453 Lot 26AMA584
Distribution
US Nationwide distribution. OUS distribution pending.
Quantity
49,654 kits total