Class 1 Device Recall Vial2Bag DC 13mm

• Date Initiated by Firm: December 26, 2018
• Date Posted: January 28, 2019
• Recall Status: Terminated on July 20, 2022
• Recall Number: Z-0767-2019
• Recall Event ID: 81877
• 510(K)Number: K170095
• Product Classification: Set, i.V. Fluid transfer - Product Code LHI
• Product: Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only
• Code Information: UDI: (01)07290108240061(17)211031(10)A839(90)3609812 5(91)6070111 Lot Numbers: 7153, 7154, 7634, 7688, 7752, 7909, 7955, 8152, 8153, 8154, 8232, 8233, 8234, 8235, 9028, 9175, 9029, 9176, 9177, 9178, 9367, 9368, 9369, 9370, 9654, 9656, 9655, 9918, 9710, 9711, 9712, 9713, 9839, 9840, 9983, 9984, 9992, 9993, 9994, 9995, A123, A124, A790, A805, A806, A791, A792, A793, A794, A795, A796, A797, A807, A808, A809, A810, A834, A835, A836, A837, A838 & A839
• Recalling Firm/ Manufacturer: WEST PHARMA. SERVICES IL, LTD; 4, Ha-Sheizaf; Ra'Anana Israel
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Device Design
• Action: On December 26, 2018, West Pharmaceutical Services, Inc. issued URGENT MEDICAL DEVICE CORRECTION and ACKNOWLEDGEMENT FORMS to their customers asking customers to avoid use of the drug oxytocin with the device. Actions to be taken by the Distributor: 1. Complete the required Acknowledgement and Receipt Form below and return (via email) to Kevin.Lentz@westpharma.com when complete (See attached form). 2. Prior to filling order / releasing shipments of any Vial2Bag DC 13mm products (which have been placed on hold per our request) to hospital customers, affix a copy of this Voluntary Field Corrective Action Notice to each carton of Vial2Bag DC 13mm products in your possession. 3. Notify and provide the letter to all accounts/customers where the Affected Product was distributed. 4. Because the assessment is ongoing, please be prepared for updates to the notification. Actions to be taken by the Customer/User: 1. As a temporary measure you should avoid use of the drug oxytocin with the Vial2Bag DC 13mm until further notice until a full assessment has been completed. 2. Affix the notice to each carton of Vial2Bag DC 13mm products in your possession. 3. In addition, provide the notice to personnel with responsibilities related to product selection and administration, and according to your internal procedures for notification of field corrective actions. 4. Please complete the Recall Acknowledgement and Receipt Form and return to Karen Crimi by email at cs@progressivemedinc.com when complete responses are available. On January 24, 2019, West Pharmaceutical Services, Inc. initiated a product removal and broadened their action by distributing AMENDED URGENT MEDICAL DEVICE RECALL notices to their customers to include removal of three (3) devices from the field. On February 1, 2019, West Pharmaceutical Services, Inc. expanded their recall to include an additional sixteen (16) lots and issued notices titled - 2nd AMENDED URGENT MEDICAL DEVICE RECALL not
• Quantity in Commerce: 3.9 million units
• Distribution: US Distributor in MO
• 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.