Data / Medical devices / Israel / West Pharma. Services IL, Ltd.
West Pharma. Services IL, Ltd.: FDA-registered device maker in Ra'anana Central, Israel, 13 510(k) clearances
West Pharma. Services IL, Ltd. is registered with the FDA (registration 3000223297) in Ra'anana Central, Israel. It lists 1 device type. The FDA files 13 510(k) clearances under its listings, the newest dated May 3, 2024. 2 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3000223297
- Address
- 4 HaSheizaf St., Ra'anana Central, Israel, 4366411
- Owner or operator
- WEST PHARMACEUTICAL SERVICES, INC. (2514921)
- Roles
- Manufacturer, Specification developer
- First device listed
- March 21, 2000
- Registered through
- 2026
- Brand names listed
- MIXJECT, MP Vial Adapter 13 mm, Mix2Vial Transfer Device, Mix2Vial® Transfer Device, MixJect® Transfer Device, Mixject Dispensing Pin, Mixject Dispensing Pin w/Detachable, Mixject Dispensing Pin with and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Set, I.V. Fluid Transfer | LHI | 2 | Manufacturer, 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 |
|---|---|---|---|---|---|---|
| May 3, 2024 | K240940 | Vial2Bag Advanced® 20mm Admixture Device | LHI | Substantially Equivalent | West Pharmaceutical Services, Inc. | accessdata.fda.gov |
| January 19, 2024 | K231071 | Mix2Vial® Transfer Device | LHI | Substantially Equivalent | West Pharma. Services IL, Ltd. | accessdata.fda.gov |
| December 14, 2023 | K232875 | Vial Adapter 20mm | LHI | Substantially Equivalent | West Pharma. Services IL, Ltd. | accessdata.fda.gov |
| December 1, 2023 | K230988 | Vial2Bag Advanced® 13mm Admixture Device | LHI | Substantially Equivalent | West Pharma. Services IL, Ltd. | accessdata.fda.gov |
| May 22, 2023 | K230464 | MixJect® Transfer Device | LHI | Substantially Equivalent | West Pharma. Services IL, Ltd. | accessdata.fda.gov |
| August 31, 2022 | K213513 | Vented Vial Adapter 20mm | LHI | Substantially Equivalent | West Pharma. Services IL, Ltd. | accessdata.fda.gov |
| May 4, 2016 | K160503 | Vented Vial Adapter Transfer Device - 13mm | LHI | Substantially Equivalent | Medimop Medical Projects, Ltd. | accessdata.fda.gov |
| August 8, 2013 | K130179 | MP VIAL ADAPTER 13MM | LHI | Substantially Equivalent | Medimop Medical Projects, Ltd. | accessdata.fda.gov |
| December 13, 2007 | K072511 | SWABABLE VIAL ADAPTER 13MM, SWABABLE VIAL ADAPTER 20MM | LHI | Substantially Equivalent | Medimop Medical Projects, Ltd. | accessdata.fda.gov |
| November 3, 2006 | K062482 | VENTED VIAL ADAPTER TRANSFER DEVICE | LHI | Substantially Equivalent | Medimop Medical Projects, Ltd. | accessdata.fda.gov |
| July 29, 2003 | K031861 | MIX2VIAL TRANSFER DEVICE | LHI | Substantially Equivalent | Medimop Medical Projects, Ltd. | accessdata.fda.gov |
| May 5, 2000 | K001293 | MODIFICATION TO MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PRE-ATTACHED NEEDLE | LHI | Substantially Equivalent | Medimop Medical Projects, Ltd. | accessdata.fda.gov |
| October 7, 1996 | K963583 | MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PREATTACHED NEEDLE | LHI | Substantially Equivalent | Medimop Medical Projects, Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 26, 2018 | 81877 | Class I | Terminated | Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only | 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. | accessdata.fda.gov |
| October 6, 2017 | 79243 | Class II | Terminated | Vial2BagDC, Product Number 6070112. The 20mm Vial2Bag DC device, is intended for use in healthcare facilities or in-home environment by the patient or care-giver to aid and support prescribed treatment and therapy. The d | Medimop is recalling certain lots of this product Vial2Bag DC due to the potential of the IV Port separating from the Via12Bag DC body during the drug reconstitution I IV Set attachment process. | accessdata.fda.gov |
Compare with other makers
Updated May 3, 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.