FDA Enforcement
Class II
Ongoing
Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250
Recall: Z-1995-2025
·
Reported July 2, 2025
Enforcement
- Recall Number
- Z-1995-2025
- Event ID
- 96959
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- MEDLINE INDUSTRIES, LP - Northfield
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 2, 2025
- Initiation Date
- May 15, 2025
- Classification Date
- June 20, 2025
- Address
- 3 Lakes Dr, Northfield, IL, 60093-2753, United States
Description
Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250
Reason
There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile product.
Code Info
UDI-DI: 10653160995340 (each), 40653160995341 (case); Lot Numbers: 25BBG881, 24KBU973, 24IBK851, 24HBQ012
Distribution
US Nationwide distribution in the state of VA.
Quantity
174 units