Vial2Bag Direct Connect

• • Terminated Z-0769-2019 FDA Class I ·initiated 26 Dec 2018

  Adverse events have been reported with the use of oxytocin in conjunction with the 13mm Vial2Bag DC in pregnant women. Vial2Bag DC 20mm is recalled due to similarities with 13mm Vial2Bag DC.

• • Terminated Z-0767-2019 FDA Class I ·initiated 26 Dec 2018

  Adverse events have been reported with the use of oxytocin in conjunction with the product in pregnant women. There is a possibility that the device may cause inadequate admixing of drug with the solution in the IV bag. This could lead to concentrated drug pooling in the device and bolus injections.

• • Terminated Z-0972-2018 FDA Class II ·initiated 6 Oct 2017

  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.

510(k) Number

K170095 ↗

FDA Product Code

LHI

FDA applicant

Medimop Medical Project , Ltd.

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Vial Connector 13mm Closed Collar

  Class II

  FDA 510(k) K132040 Active Cleared 31 Jul 2013

• Modification to Mixject Dispensing Pin/with Detachable Vial Holder/with Detachable Vial Holder and Pre-Attached Needle

  Class II

  FDA 510(k) K001293 Active Cleared 5 May 2000

• MIX2VIAL Transfer Device

  Class II

  FDA 510(k) K031861 Active Cleared 29 Jul 2003

• Vial Adapter 15mm

  Class II

  FDA 510(k) K171796 Active Cleared 12 Oct 2017

• Mixject Dispensing Pin/with Detachable Vial Holder/with Detachable Vial Holder and Preattached Needle

  Class II

  FDA 510(k) K963583 Active Cleared 7 Oct 1996

• Mixject with Spray Head

  Class II

  FDA 510(k) K122023 Active Cleared 4 Oct 2012

See all devices from Medimop Medical Projects, Ltd. →