West Pharma. Services IL, Ltd.
Ra'anana Central, IL
West Pharma. Services IL, Ltd. appears in FDA device records in Ra'anana Central, IL. FDA records list 17 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to West Pharma. Services IL, Ltd. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Medimop Medical Projects, Ltd.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 17 510(k) clearances for West Pharma. Services IL, Ltd. between 1996 and 2024. The busiest year on record is 2023, with 3. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 1 |
| 2000 | 2 |
| 2003 | 1 |
| 2006 | 1 |
| 2007 | 2 |
| 2012 | 1 |
| 2013 | 2 |
| 2014 | 1 |
| 2016 | 1 |
| 2022 | 1 |
| 2023 | 3 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K231071 | Mix2Vial® Transfer Device | LHI | Substantially Equivalent | |
| K232875 | Vial Adapter 20mm | LHI | Substantially Equivalent | |
| K230988 | Vial2Bag Advanced® 13mm Admixture Device | LHI | Substantially Equivalent | |
| K230464 | MixJect® Transfer Device | LHI | Substantially Equivalent | |
| K213513 | Vented Vial Adapter 20mm | LHI | Substantially Equivalent | |
| K160503 | Vented Vial Adapter Transfer Device - 13mm | LHI | Substantially Equivalent | |
| K140730 | VIAL2BAG DIRECT CONNECT | LHI | Substantially Equivalent | |
| K130179 | MP VIAL ADAPTER 13MM | LHI | Substantially Equivalent | |
| K132040 | VIAL CONNECTOR 13MM CLOSED COLLAR | LHI | Substantially Equivalent | |
| K122023 | MIXJECT WITH SPRAY HEAD | FMF | Substantially Equivalent | |
| K072759 | VIAL2BAG | LHI | Substantially Equivalent | |
| K072511 | SWABABLE VIAL ADAPTER 13MM, SWABABLE VIAL ADAPTER 20MM | LHI | Substantially Equivalent | |
| K062482 | VENTED VIAL ADAPTER TRANSFER DEVICE | LHI | Substantially Equivalent | |
| K031861 | MIX2VIAL TRANSFER DEVICE | LHI | Substantially Equivalent | |
| K001831 | NEEDLELESS TRANSFER DEVICE | LHI | Substantially Equivalent | |
| K001293 | MODIFICATION TO MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PRE-ATTACHED NEEDLE | LHI | Substantially Equivalent | |
| K963583 | MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PREATTACHED NEEDLE | LHI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3000223297 | 3000223297 | West Pharma. Services IL, Ltd. | 4 HaSheizaf St., Ra'anana Central 4366411 IL | 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-0769-2019 | Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C, Single use only, Rx Only | Adverse events have been reported with the use of oxytocin in conjunction with the 13mm Vial2Bag DC in pregnant women. Vial2Bag DC 20mm is recalled due to similarities with 13mm Vial2Bag DC. | Class I | Terminated | |
| Z-0768-2019 | Vial2BAG Transfer Device, REF 6070104, Single use only, Rx Only | Adverse events have been reported with the use of oxytocin in conjunction with the 13mm Vial2Bag DC in pregnant women. Vial2Bag is recalled due to similarities with 13mm Vial2Bag DC. | Class I | Terminated | |
| Z-0767-2019 | 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. | Class I | Terminated | |
| Z-0972-2018 | 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 device consists of the Vial2Bag piercing spike and cover, the IV Port connector and an integrated Vial Adapter (20mm) for access to the drug/solution vial. | 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. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain