The Recall Desk
HighFDA (Devices)·Z-0972-2018·Announced 2018-03-21

Medimop Recalls Vial2Bag DC Devices Due to IV Port Separation Risk

Medimop is recalling specific lots of Vial2Bag DC devices because the IV Port may separate from the body during use.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a structural defect (IV Port separation) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medimop Medical Projects Ltd. is recalling certain lots of the Vial2Bag DC device, Product Number 6070112. The recall involves 453,600 units distributed in the United States. The affected lots are 9507, 9508, 9509, 9510, 9511, 9512, and 9513.

The recall is being conducted because the IV Port may separate from the Vial2Bag DC body during the drug reconstitution or IV Set attachment process. The device is intended for use in healthcare facilities or in-home environments by patients or caregivers to aid and support prescribed treatment and therapy.

Consumers and healthcare facilities should stop using the affected devices and contact Medimop for further instructions.

The recalled product

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 cove
Affected units
453,600

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • Lots: 9507
  • 9508
  • 9509
  • 9510
  • 9511
  • 9512
  • 9513.

Distribution

Distribution scope not specified by the agency.