Device product
Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250
Z-1995-2025
Product summary
- Event
- Event 96959
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 174 units
- Official record key
device-enforcement:Z-1995-2025
Official wording
Reason: There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile product.
Code information: UDI-DI: 10653160995340 (each), 40653160995341 (case); Lot Numbers: 25BBG881, 24KBU973, 24IBK851, 24HBQ012
Distribution pattern: US Nationwide distribution in the state of VA.
Derived failure modes
-
Labeling or packaging
packaging defect
-
Sterility assurance
packaging defect impacting the outer Tyvec pouch that protects the sterile