Device product
Medline Leg bag, REF URO12573
Z-0535-2024
Product summary
- Event
- Event 93306
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 144 devices
- Official record key
device-enforcement:Z-0535-2024
Official wording
Reason: Undeclared latex
Code information: UDI/DI 20888277719290 (case), 10888277719293 (insert), Lot Numbers: 48623050001, 48623060001
Distribution pattern: US and Panama
Derived failure modes
-
Unknown
Undeclared latex