Device product
Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Model/Catalog Number: 5433742 Software Version: N/A Product Description: CELSITE BABYPORT SET PUR 4,5F IV USA Component: N/A
Z-2528-2025
Product summary
- Event
- Event 97407
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 58 units
- Official record key
device-enforcement:Z-2528-2025
Official wording
Reason: The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall.
Code information: Model/Catalog Number: 5433742; Primary-DI 04046963594947; Lot 37041185; Exp 19MAR2030;
Distribution pattern: US Nationwide distribution in the state of PA.
Derived failure modes
-
Unknown
The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall.