West Pharmaceutical Services AZ, Inc.
Tempe, AZ, US
West Pharmaceutical Services AZ, Inc. appears in FDA device records in Tempe, AZ. FDA records list one 510(k) clearance, no PMA records and 3 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for West Pharmaceutical Services AZ, Inc. in 2020.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2020 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2025648 | 2025648 | West Pharmaceutical Services AZ, Inc. | 640 S Rockford Dr, TEMPE, AZ 85288 US | 2026 | |
| 2032862 | 3001155023 | West Pharmaceutical Services AZ, Inc. | 14677 NORTH 74TH ST., SCOTTSDALE, AZ 85260 US | 2026 | |
| 3015176617 | 3015176617 | West Pharmaceutical Services AZ, Inc. | 7400 E. Tierra Buena Ln, Ste 101, Scottsdale, AZ 85260 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0283-2025 | 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 administration port. The device consists of the body, Protector, IV Port, and an integrated vial adapter. The device is provided as a sterile, non-pyrogenic product. The device is intended to be used with standard drug vials with a seal diameter of 20mm and an elastomeric stopper. The Vial2Bag Advanced 20mm Admixture Device is designed to work with a standard 50, 100, or 250mL IV bag and an external IV administration set. The device does not contain any medicinal substances and there are no additional accessories needed or provided with the Vial2Bag Advanced 20mm Admixture Device for the device to meet its intended purpose. Component: No | Due to packaging damage from heat exposure during shipping/transportation that may result in a breach in the sterile barrier. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain