CLASS II Device recall · Reported 21 Mar 2018 · FDA Enforcement Report
Vial2BagDC, Product Number recalled by Medimop Medical Projects
Medimop Medical Projects is recalling Vial2BagDC, Product Number 6070112. The recall was initiated on 6 Oct 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0972-2018
- FDA event ID
- 79243
- Recalling firm
- Medimop Medical Projects, Raanana
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Oct 2017
- FDA classified
- 12 Mar 2018
- Reported
- 21 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 6 Oct 2017 | Recall initiated by company | |
| 12 Mar 2018 | Classified by FDA | +157 days |
| 21 Mar 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
US Distribution
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lots: 9507,9508,9509,9510,9511,9512,9513.
Where was it sold?
US Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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