FDA Enforcement
Class II
Ongoing
Medline Kits: 1) PICC TRAY, Model Number: DYNJ41648A
Recall: Z-1837-2026
·
Reported April 29, 2026
Enforcement
- Recall Number
- Z-1837-2026
- Event ID
- 98599
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Medline Industries, LP
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 29, 2026
- Initiation Date
- February 25, 2026
- Classification Date
- April 17, 2026
- Address
- 3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States
Description
Medline Kits: 1) PICC TRAY, Model Number: DYNJ41648A
Reason
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Code Info
1) DYNJ41648A, UDI-DI: 10198459062834(each), 40198459062835(case), Lot Number: 25CLA242; 2) DYNJ41648A, UDI-DI: 10198459062834(each), 40198459062835(case), Lot Number: 24LLA758
Distribution
US Nationwide distribution.
Quantity
20 units