Recall Record

Scottsdale, AZ, United States

West Pharmaceutical Services AZ, Inc. recalls

1 recall recorded since 2018, most recently on 24 September 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.

Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0

Ongoing Class II Medical devices

Recall started
24 September 2024
Reason
Due to packaging damage from heat exposure during shipping/transportation that may result in a breach in the sterile barrier.
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,
Initiated
Voluntary: Firm initiated
Recall number
Z-0283-2025

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.