Recall Z-0283-2025 ยท LHI Set, I.V. Fluid Transfer
West Pharmaceutical Services AZ, Inc.
Brand Name: Vial2Bag Advanced Product Name: Vial2Bag Advanced 20mm Admixture Device Model/Catalog Number: 6070030 Software Version: Not applicable Product Description: The Vial2Bag Advanced 20mm Admixture Device is a single use, fluid transfer device that allows for the reconstitution and transfer of fluids from drug vials into the IV bag containing infusion solution, through the IV bag administra
| Date | Nov 1, 2024 (initiated Sep 24, 2024) |
| Status | Open, Classified |
| Reason | Due to packaging damage from heat exposure during shipping/transportation that may result in a breach in the sterile barrier. |
| Root cause | Environmental control |
| Action | On 09/24/2024, the firm emailed an "URGENT: MEDICAL DEVICE RECALL" Letter informing customers that due to possible package damage during shipping and transportation, which may result in breach in sterile barrier that compromises the safety and efficacy of the devices. Distributor are instructed to: 1. Examine their inventory and quarantine Affected Product subject to this voluntary recall. 2. If the Affected Product was distributed to additional customers, send them this letter. 3. Follow up with each account/customer to locate and identify all Affected Product in Appendix 1 and establish the |
| Quantity | 129600 |
| Distribution | A U.S. Distributor, Progressive Medical Inc. (PMI) currently supplies the Vial2Bag Advanced 20mm Admixture Device to hospitals in the U.S. (end user). PMI distributed the impacted Vial2Bag Advanced 20mm Admixture Device lots to the end users. U.S.: Distributor located in MO U.S. Customers: AL, AR, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201415 | Vial2Bag Advanced 20mm Admixture Device West Pharmaceutical Services Az, Inc., Oct 21, 2020 |