FDA Enforcement
Class II
Ongoing
Medline Kits: 1) BREAST PACK, Model Number: DYNJ66777D
Recall: Z-1841-2026
·
Reported April 29, 2026
Enforcement
- Recall Number
- Z-1841-2026
- 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) BREAST PACK, Model Number: DYNJ66777D
Reason
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Code Info
1) DYNJ66777D, UDI-DI: 10195327365196(each), 40195327365197(case), Lot Number: 24JBX593
Distribution
US Nationwide distribution.
Quantity
36 units