RegWardenFDA facility compliance records
Facility

BD SWITZERLAND SARL

2 recall(s) on record — most severe on record: Class I.

Activity by year

FDA actions on record by year2013: 2 recalls2’13’14’15’16’17’18’19’20’21’22’23’24’25’26
  • Recalls (2)

Devices registered here (1)

  • Set, Administration, Intravascular
    Product code FPA (opens in a new tab) · Class II · General Hospital · 21 CFR 880.5440

Recalls & enforcement

  • Class IITerminated2013-03-06
    The recall was initiated because Carefusion has identified potential risk associated with bolus programming with the Alaris PC unit (model 8015) software version 9.12. Automating infusion pump parameter input from either the electronic medical record (EMR) or the Alaris Auto-ID …
  • Class ITerminated2013-03-06
    The recall was initiated because Carefusion has received reports of a communication error on the Alaris PC unit model 8015 with software version 9.12 when the Alaris EtCO2 module or Alaris SpO2 module is attached.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “BD SWITZERLAND SARL (FEI 3012798826) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3012798826-bd-switzerland-sarl/

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