Data / Medical devices / United States / West Pharmaceutical Services AZ, Inc.
West Pharmaceutical Services AZ, Inc.: FDA-registered device maker in Scottsdale, AZ, United States, 1 510(k) clearance
West Pharmaceutical Services AZ, Inc. is registered with the FDA (registration 3015176617) in Scottsdale, AZ, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 21, 2020. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015176617
- Address
- 7400 E. Tierra Buena Ln, Ste 101, Scottsdale, AZ, United States, 85260
- Owner or operator
- WEST PHARMACEUTICAL SERVICES, INC. (2514921)
- Roles
- Specification developer
- First device listed
- October 28, 2020
- Registered through
- 2026
- Brand names listed
- Vial2Bag 20mm Admixture Device
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Set, I.V. Fluid Transfer | LHI | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 21, 2020 | K201415 | Vial2Bag Advanced 20mm Admixture Device | LHI | Substantially Equivalent | West Pharmaceutical Services Az, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 24, 2024 | 95449 | Class II | Ongoing | 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 sin | Due to packaging damage from heat exposure during shipping/transportation that may result in a breach in the sterile barrier. | accessdata.fda.gov |
Compare with other makers
Updated November 1, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.