Device product
Medline Leg bag, REF DYND12574
Z-0533-2024
Product summary
- Event
- Event 93306
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 28942 devices
- Official record key
device-enforcement:Z-0533-2024
Official wording
Reason: Undeclared latex
Code information: UDI/DI 40080196990338 (case), 10080196990337 (insert), Lot Numbers: 48623040001, 48623050001, 48623060001, 48623080001
Distribution pattern: US and Panama
Derived failure modes
-
Unknown
Undeclared latex