Horizon Pump Y-Type Blood Set

• 3 recalls, same reason

  • Ongoing Z-0620-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0619-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0618-2026 FDA Class II ·initiated 29 Oct 2025

  Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

• 4 recalls, same reason

  • Terminated Z-2548-2021 FDA Class II ·initiated 10 Aug 2021
  • Terminated Z-2553-2021 FDA Class II ·initiated 10 Aug 2021
  • Terminated Z-2559-2021 FDA Class II ·initiated 10 Aug 2021
  • Terminated Z-2560-2021 FDA Class II ·initiated 10 Aug 2021

  Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.

• 3 recalls, same reason

  • Terminated Z-0935-2020 FDA Class II ·initiated 20 Nov 2019
  • Terminated Z-0937-2020 FDA Class II ·initiated 20 Nov 2019
  • Terminated Z-0939-2020 FDA Class II ·initiated 20 Nov 2019

  Potential for leakage at the joint between the blood filters and tubing

• • Terminated Z-0718-2010 FDA Unclassified (pre-2012) ·initiated 24 Nov 2009

  System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initiation sequence and will not allow the set to be utilized. This requires a new set to be obtained, thus creating a potential for delay in therapy.

510(k) Number

K922637 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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