CAREFUSION

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

Devices registered here (1)

• Set, Administration, Intravascular
  Product code FPA · Class II · General Hospital · 21 CFR 880.5440

Recalls & enforcement

• Class IIOngoing2022-08-01
  Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and
• Class IIOngoing2021-08-02
  Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was
• Class IITerminated2021-06-09
  A portion of a validation lot was inadvertently released to the US Market. The product did not meet the validation testing criteria regarding leakage.
• Class IITerminated2009-11-20
  The recall was initiated because Carefusion has confirmed that when the PAS 2000 drawers due to inaccessability of drawers caused by system down time or lock-up.

Related

• All facilities operated by CareFusion

Source: U.S. FDA via openFDA (device registration & enforcement). Data as of 2026-08-13. Verify this facility record at FDA →