Z-0972-2018 Class II Terminated
FDA device recall Z-0972-2018 was initiated by Medimop Medical Projects Ltd. on October 6, 2017 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated January 23, 2024). Affected quantity: 453,600 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 21, 2018
- Initiation Date
- October 6, 2017
- Termination Date
- January 23, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 453,600 units
Product Description
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.
Reason for Recall
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.
Distribution Pattern
US Distribution
Code Information
Lots: 9507,9508,9509,9510,9511,9512,9513.