Data / Medical devices / Switzerland / BD Switzerland Sarl
BD Switzerland Sarl: FDA-registered device maker in Eysins Vaud, Switzerland, 35 510(k) clearances
BD Switzerland Sarl is registered with the FDA (registration 3012798826) in Eysins Vaud, Switzerland. It lists 7 device types. The FDA files 35 510(k) clearances under its listings, the newest dated October 30, 2025. 9 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3012798826
- Address
- Terre Bonne Park - A4 Route de Crassier 17, Eysins Vaud, Switzerland, 1262
- Owner or operator
- CareFusion (10062808)
- Roles
- Manufacturer
- First device listed
- March 25, 2020
- Registered through
- 2026
- Brand names listed
- BD Alaris Infusion Set, BD Alaris Pump Infusion Set, BD Male/Female Luer Lock Cap, BD PhaSeal, BD PhaSeal Optima, BD PhaSeal Optima, BD SmartSite Vial Access Device, BD SmartSite Needle-Free Connector and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | ONB | 2 | Manufacturer | accessdata.fda.gov |
| Device, Intravascular Catheter Securement | KMK | 1 | Manufacturer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Manufacturer | accessdata.fda.gov |
| Set, I.V. Fluid Transfer | LHI | 2 | Manufacturer | accessdata.fda.gov |
| Stand, Infusion | FOX | 1 | Manufacturer | accessdata.fda.gov |
| Stopcock, I.V. Set | FMG | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Manufacturer | 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 30, 2025 | K250325 | BD Alaris Pump Infusion Set | FPA | Substantially Equivalent | Carefusion (Bd) | accessdata.fda.gov |
| September 12, 2025 | K250059 | BD PhaSeal Optima Connecting Set (C83-O); BD PhaSeal Optima Spike Set (C180-O) | ONB | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| March 6, 2024 | K233021 | BD SmartSite 13mm Vial Access Device; BD SmartSite 20mm Vial Access Device | LHI | Substantially Equivalent | Care Fusion | accessdata.fda.gov |
| September 25, 2023 | K231888 | BD Texium Needle-Free Syringe | FMF | Substantially Equivalent | Care Fusion | accessdata.fda.gov |
| July 21, 2023 | K221327 | BD Alaris Pump Infusion Sets | FPA | Substantially Equivalent | Care Fusion | accessdata.fda.gov |
| April 7, 2023 | K223088 | BD SmartSite Needle-Free Connector | FPA | Substantially Equivalent | Care Fusion | accessdata.fda.gov |
| March 24, 2023 | K223076 | BD Texium Closed Male Luer | ONB | Substantially Equivalent | Care Fusion | accessdata.fda.gov |
| August 12, 2020 | K201099 | BD PhaSeal Optima Closed System Drug Transfer Device | ONB | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| November 30, 2018 | K181221 | BD PhaSeal Optima Closed System Transfer Device | ONB | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| July 19, 2017 | K171957 | MaxZero Extension Sets with Needless Connector | FPA | Substantially Equivalent | Carefusion 303, Inc. | accessdata.fda.gov |
| November 20, 2014 | K143234 | MaxZero Administration Sets | FPA | Substantially Equivalent | Care Fusion | accessdata.fda.gov |
| May 14, 2014 | K140591 | BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - INJECTOR | ONB | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| April 15, 2014 | K140831 | MAXZERO EXTENSION SET WITH NEEDLESS CONNECTOR | FPA | Substantially Equivalent | Care Fusion | accessdata.fda.gov |
| August 29, 2013 | K132413 | MZ1000 | FPA | Substantially Equivalent | Care Fusion | accessdata.fda.gov |
| February 27, 2013 | K130197 | BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - P55 | ONB | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| January 9, 2013 | K123213 | BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE | ONB | Substantially Equivalent | Becton, Dickinson & CO | accessdata.fda.gov |
| December 9, 2008 | K083472 | MEDEGEN PRESSURE RATED EXTENSION SETS | FPA | Substantially Equivalent | Medegen, Inc. | accessdata.fda.gov |
| December 14, 2007 | K071400 | SMARTSITE STOPCOCK | FMG | Substantially Equivalent | Cardinal Health, Alaris Products | accessdata.fda.gov |
| September 25, 2007 | K072542 | MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTOR | FPA | Substantially Equivalent | Medegen Medical Manufacturing System | accessdata.fda.gov |
| July 26, 2006 | K061285 | SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETS | FPA | Substantially Equivalent | Cardinal Health, Alaris Products | accessdata.fda.gov |
| August 16, 2005 | K051930 | DRUG ACCESS SPIKE | FMF | Substantially Equivalent | Medegen Medical Manufacturing Services | accessdata.fda.gov |
| June 22, 2005 | K051499 | INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET | FPA | Substantially Equivalent | Medegen Medical Manufacturing Services | accessdata.fda.gov |
| August 6, 2002 | K022209 | ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS | FPA | Substantially Equivalent | Alaris Medical Systems, Inc. | accessdata.fda.gov |
| November 2, 1999 | K993147 | DECAP | FPA | Substantially Equivalent | The Kipp Group | accessdata.fda.gov |
| April 21, 1997 | K970485 | SMARTSITE ACCESS PIN | FPA | Substantially Equivalent | Ivac Medical Systems | accessdata.fda.gov |
| April 4, 1996 | K960280 | IVAC NEEDLE FREE VALVE ADMINISTRATION SETS | FPA | Substantially Equivalent | Y | accessdata.fda.gov |
| July 19, 1995 | K951922 | ADMINISTRATION SETS WITH BALL FLOAT | FPA | Substantially Equivalent | Imed Corp. | accessdata.fda.gov |
| February 14, 1995 | K944320 | VENTED/NON-VENTED GEMINI ADMINISTRATION SET | FPA | Substantially Equivalent | Imed Corp. | accessdata.fda.gov |
| January 13, 1995 | K945070 | VERSASAE PLASTIC CANNULA- 11 GAUGE | FPA | Substantially Equivalent | Imed Corp. | accessdata.fda.gov |
| July 12, 1988 | K882302 | IVAC(R) UNVENTED VOL. INFUSION SET MODEL 52080 | FPA | Substantially Equivalent | Y | accessdata.fda.gov |
| February 18, 1982 | K820278 | INTRAVASCULAR ADMINISTRATION SET | FPA | Substantially Equivalent | Y | accessdata.fda.gov |
| August 25, 1981 | K811885 | 30-30-2 700 SYRINGE EXTENSION SET | FPA | Substantially Equivalent | Y | accessdata.fda.gov |
| May 29, 1979 | K790582 | INTRAVASCULAR ADMINISTRATION SET | FPA | Substantially Equivalent | Y | accessdata.fda.gov |
| March 6, 1979 | K790108 | FILTERSET 0.22, I.V. PUMP | FPA | Substantially Equivalent | Imed Corp. | accessdata.fda.gov |
| February 21, 1978 | K780130 | BURETTE INTRAVENOUS ADMIN. SETS. | FPA | Substantially Equivalent | Y | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 19, 2026 | 99298 | Class I | Ongoing | BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD Alaris Pump Infusion Set, 15 Micron Filter, Back Check Valve, 3 SmartSite Y-sites 10015861A 10885403232626 50885403232624 BD Alaris Pump Infusion Se | Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance. | accessdata.fda.gov |
| June 16, 2026 | 99264 | Class II | Ongoing | 60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus Ext Set w/Needleless and Y-Site REF MPX5305-C UDI-DI code: 10885403274619 9 IN Extension Set w/Max Y REF MPX5300-C UDI-DI code: 1088540 | Due to mechanical issue with internal sterilization equipment resulting in potential underdosing of product during processing, which may have resulted in products not being sterilized correctly. | accessdata.fda.gov |
| June 4, 2026 | 99085 | Class II | Ongoing | MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number: SAM2461 UDI code: N/A Engineering Sample/Not for Human Use | Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market. | accessdata.fda.gov |
| May 21, 2026 | 98855 | Class II | Ongoing | BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" Stopcocks are used to administer fluids or medication through one or two different ports via an IV cannula or extension tube. The ports ca | Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or continue to spin rather than tightening securely. This behavior has led some clinical users to perceive the connection as unstable. | accessdata.fda.gov |
| June 16, 2025 | 97070 | Class II | Ongoing | BD PhaSeal Injector Luer (N30C), REF: 515001 BD PhaSeal Injector Luer Lock (N35), REF: 515003 BD PhaSeal Injector Luer Lock (N35C), REF: 515004 BD PhaSeal Injector Lu63er Lock (N35C Multi), REF: 515005 BD PhaSeal Protect | Closed system drug transfer devices were shipped to the U.S. market without a U.S. version of the instructions for use, which could be an issue if a healthcare professional is prompted to review it. | accessdata.fda.gov |
| May 12, 2025 | 96737 | Class II | Ongoing | Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2 SmartSite Y-Sites, REF: 10013361T; SmartSite Bag Access Non-Vented Bonded Texium Closed Male Luer With Priming C | Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication. | accessdata.fda.gov |
| February 20, 2025 | 96399 | Class II | Ongoing | BD Connecta BD Luer-Lok 360, REF 394910 UDI-DI code: 00382903949106 Connecta Plus 1 and Connecta Plus 3 2-way and 3-way Stopcocks are control valves for use in IV. therapy and hemodynamic pressure monitoring. | Due to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instruction for Use (IFU) | accessdata.fda.gov |
| April 18, 2024 | 94479 | Class II | Ongoing | Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite Y Sites REF 10013072 Tubing set used for delivery of fluids, medication, blood and blood products. | Due to infusion set tubing drip chamber becoming detached from the tubing potentially causing delays in treatment, or unintentionally exposing users to harsh infusates. | accessdata.fda.gov |
| April 9, 2020 | 85525 | Class II | Terminated | BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-07 - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Use Aseptic Techniq | The products have the potential to leak between the connection of the male luer and the yellow striped tubing. This leak may be observed while priming or during use. The most likely health consequence associated with a leak in an administration set would be inadequate pain control for the patient due to an under-infusion of medication. | accessdata.fda.gov |
Compare with other makers
- All makers of Set, Administration, Intravascular
- All makers of Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
- All makers of Device, Intravascular Catheter Securement
- All makers of Syringe, Piston
- All makers of Stopcock, I.V. Set
- All makers of Stand, Infusion
Updated September 15, 2026. 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.