RegWardenFDA facility compliance records
Facility

Pfizer Service Company BV

3 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2016: 2 recalls; 2018: 1 recalls2201620171201820192020202120222023202420252026
  • Recalls (3)

Devices registered here (1)

Recalls & enforcement

  • Class IITerminated2018-10-02
    The firm received complaints of the wrap coming apart and leaking granular material
  • Class IITerminated2016-12-30
    Depleted Battery alarm shows instead of Replace Battery. On battery power, ongoing therapy stops, alarms show and sound, pump shuts down after 3 minutes. On AC power, the pump reboots (takes about 25 seconds). Therapy can resume. AC power interruption of 3-7 seconds prompts an …
  • Class IITerminated2016-07-28
    Hospira MedNet 6.1 software, in combination with the SapphirePlus 13.1x infusion pump, may result in incorrect bolus amount calculations for drugs whose concentrations are listed in Million Units.

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. “Pfizer Service Company BV (FEI 3002522469) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002522469-pfizer-service-company-bv/

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