Recall Z-0767-2019 ยท LHI Set, I.V. Fluid Transfer
WEST PHARMA. SERVICES IL, LTD
Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only
| Date | Jan 28, 2019 (initiated Dec 26, 2018) |
| Status | Terminated |
| Reason | 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 | 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 Corre |
| Quantity | 3.9 million units |
| Distribution | US Distributor in MO |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170095 | Vial2Bag Direct Connect Medimop Medical Project , Ltd., Mar 8, 2017 |