RegWardenFDA facility compliance records
Facility

PHARMACIA & UPJOHN COMPANY LLC

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

Activity by year

FDA actions on record by year2016: 2 recalls; 2017: 1 inspections; 2018: 1 recalls, 1 inspections22016120172201820192020202120222023202420252026
  • Recalls (3)
  • Inspections (2)

Devices registered here (1)

  • Agent, Absorbable Hemostatic, Collagen Based
    Product code LMF (opens in a new tab) · Class III · General, Plastic Surgery · 21 CFR 878.4490

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.

FDA inspections (2)

  • VAI2018-12-10
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
  • VAI2017-12-22
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

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. “PHARMACIA & UPJOHN COMPANY LLC (FEI 1810189) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1810189-pharmacia-upjohn-company-llc/

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