Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only

FDA device recall Z-0767-2019 · posted 2019-01-28 · Terminated

Recall details

Recalling firm

WEST PHARMA. SERVICES IL, LTD

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.

Action taken

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

Root cause

Device Design

Status

Terminated

Product code

LHI

Quantity affected

3.9 million units

Distribution

US Distributor in MO

Date initiated

2018-12-26

Date posted

2019-01-28

Date terminated

2022-07-20

Location

Ra'Anana, Israel

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