Device product
SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 4000mL, (legless) REF 66640 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Z-0003-2020
Product summary
- Event
- Event 83509
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1512 bags
- Official record key
device-enforcement:Z-0003-2020
Official wording
Reason: Potential for leaking product
Code information: Lot Numbers: 66640-A2404, 66640-A4324
Distribution pattern: US Nationwide distribution including the states of PA, MA, IL CA.
Derived failure modes
-
Unknown
Potential for leaking product