FDA recall Z-1995-2025
MEDLINE INDUSTRIES, LP - Northfield · Class II · device
Product
Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250
Reason for recall
There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile product.
Distribution
US Nationwide distribution in the state of VA.
Key facts
- Status
- Ongoing
- Initiation date
- 2025-05-15
- Report date
- 2025-07-02
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Northfield, IL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1995-2025