Z-0767-2019Class I

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

Name: Z-0767-2019 Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only
Creator: West Pharma. Services Il, Ltd
Published: 2018-12-26
License: https://open.fda.gov/license/

West Pharma. Services IL, Ltd. / initiated 2018-12-26 / Terminated / root cause: design

FDA source

WEST PHARMA. SERVICES IL, LTD began a recall of Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only on 2018-12-26. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0767-2019
Classification: Class I
Status: Terminated
Initiated: 2018-12-26
Posted: 2019-01-28
Terminated: 2022-07-20
Recalling firm: West Pharma. Services IL, Ltd.
Product: Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only
Product code: LHI Set, I.V. Fluid Transfer
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.
Root cause tag: design
FDA root 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 [email protected] 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 [email protected] 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0767-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0767-2019	Class I	Terminated	Voluntary: Firm initiated	2019-02-06	2019-01-28
Z-0768-2019	Class I	Terminated	Voluntary: Firm initiated	2019-02-06	2019-01-28
Z-0769-2019	Class I	Terminated	Voluntary: Firm initiated	2019-02-06	2019-01-28

Product code LHI

K170095Class IIVial2Bag Direct ConnectMedimop Medical Project , Ltd. / cleared 2017-03-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)