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U.S. Department of Health and Human Services

Class 2 Device Recall Via2BagDirect Connect

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  Class 2 Device Recall Via2BagDirect Connect see related information
Date Initiated by Firm October 06, 2017
Create Date March 12, 2018
Recall Status1 Terminated 3 on January 23, 2024
Recall Number Z-0972-2018
Recall Event ID 79243
510(K)Number K170095  K140730  
Product Classification Set, i.V. Fluid transfer - Product Code LHI
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.
Code Information Lots: 9507,9508,9509,9510,9511,9512,9513.
Recalling Firm/
Manufacturer		 Medimop Medical Projects Ltd.
4 Hayetzira Street,
P.O. Box 2499
Raanana Israel
For Additional Information Contact
610-594-4353
Manufacturer 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.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LHI and Original Applicant = Medimop Medical Project Ltd.
510(K)s with Product Code = LHI and Original Applicant = MEDIMOP MEDICAL PROJECTS, LTD.
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