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.
FDA Recall Z-0972-2018 · Posted None
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Recalling FirmMedimop Medical Projects Ltd.
Recall StatusTerminated
Product CodeLHI
Date Initiated2017-10-06
Date Terminated2024-01-23
Product Quantity453,600 units
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.
Firm Action
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.
Root Cause
Process control
Distribution Pattern
US Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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