Device product
Vial2BagDC, Product Number 6070112. The 20mm Vial2Bag DC device, is intended for use in healthcare facilities or in-home environment by the patient or care-giver to aid and support prescribed treatment and therapy. The device consists of the Vial2Bag piercing spike and cover, the IV Port connector and an integrated Vial Adapter (20mm) for access to the drug/solution vial.
Z-0972-2018
Product summary
- Event
- Event 79243
- Status
- Terminated
- Classification
- Class II
- Quantity
- 453,600 units
- Official record key
device-enforcement:Z-0972-2018
Official wording
Reason: Medimop is recalling certain lots of this product Vial2Bag DC due to the potential of the IV Port separating from the Via12Bag DC body during the drug reconstitution I IV Set attachment process.
Code information: Lots: 9507,9508,9509,9510,9511,9512,9513.
Distribution pattern: US Distribution
Derived failure modes
-
Unknown
Medimop is recalling certain lots of this product Vial2Bag DC due to the potential of the IV Port separating from the Via12Bag DC body during the drug reconstitution I IV Set attachment process.