Recall Z-0972-2018
Medimop Medical Projects Ltd. · initiated October 6, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lots: 9507,9508,9509,9510,9511,9512,9513.
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.
FDA-determined cause: Process control
Action taken
The recalling firm's sent an Urgent Medical Device Recall Letter dated October 13, 2017. was supplied to the consignee which contains the instructions for the recall process to the consignee. The notification letter will be sent to the Distributor via email. The notification letter instructs the distributor to notify the Customer/Users via the Medimop consignee recall letter. For further questions, please call (610) 594-4353.
Details
- Recall number
- Z-0972-2018
- Initiated
- October 6, 2017
- Terminated
- January 23, 2024
- Product code
- LHI – Set, I.V. Fluid Transfer
- Quantity
- 453,600 units
- Distribution
- US Distribution
- Recalling firm
- Medimop Medical Projects Ltd., Raanana