IV Set with Graduated Chamber

• 2 recalls, same reason

  • Ongoing Z-0622-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0621-2026 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).

• 2 recalls, same reason

  • Terminated Z-2549-2021 FDA Class II ·initiated 10 Aug 2021
  • Terminated Z-2547-2021 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.

• 5 recalls, same reason

  • Terminated Z-2414-2008 FDA Unclassified (pre-2012) ·initiated 30 Jun 2008
  • Terminated Z-2413-2008 FDA Unclassified (pre-2012) ·initiated 30 Jun 2008
  • Terminated Z-2410-2008 FDA Unclassified (pre-2012) ·initiated 30 Jun 2008
  • Terminated Z-2412-2008 FDA Unclassified (pre-2012) ·initiated 30 Jun 2008
  • Terminated Z-2411-2008 FDA Unclassified (pre-2012) ·initiated 30 Jun 2008

  incorrect burette was packaged with the product

510(k) Number

K781744 ↗

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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• I.V. Administration Set with Mini-Spike Open recall

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• Zeon Composite Resin System

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  FDA 510(k) K820006 Active Cleared 22 Jan 1982

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