Z-0972-2018Class II

Vial2BagDC, Product Number 6070112. The 20mm Vial2Bag DC device, is intended for use in healthcare facilities...

Name: Z-0972-2018 Vial2BagDC, Product Number 6070112. The 20mm Vial2Bag DC device, is intended for use in healthcare facilities...
Creator: Medimop Medical Projects Ltd.
Published: 2017-10-06
License: https://open.fda.gov/license/

West Pharma. Services IL, Ltd. / initiated 2017-10-06 / Terminated / root cause: manufacturing process

FDA source

Medimop Medical Projects Ltd. began a recall of Vial2BagDC, Product Number 6070112. The 20mm Vial2Bag DC device, is intended for use in healthcare facilities or in-home environment by the patient or... on 2017-10-06. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0972-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-06
Posted: 2018-03-12
Terminated: 2024-01-23
Recalling firm: West Pharma. Services IL, Ltd.
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.
Product code: LHI Set, I.V. Fluid Transfer
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.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 453,600 units
Distribution: US Distribution
Product codes and lots: Lots: 9507,9508,9509,9510,9511,9512,9513.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0972-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0972-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-12

Product code LHI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)