Safeline System IV Administration Sets & Component

• 6 recalls, same reason

  • Ongoing Z-0677-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0701-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0700-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0702-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0713-2026 FDA Class II ·initiated 29 Oct 2025
  • Ongoing Z-0632-2026 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).

• 3 recalls, same reason

  • Terminated Z-2560-2021 FDA Class II ·initiated 10 Aug 2021
  • Terminated Z-2555-2021 FDA Class II ·initiated 10 Aug 2021
  • Terminated Z-2559-2021 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.

• • Terminated Z-0940-2020 FDA Class II ·initiated 20 Nov 2019

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

• 6 recalls, same reason

  • Terminated Z-0702-2010 FDA Unclassified (pre-2012) ·initiated 24 Nov 2009
  • Terminated Z-0695-2010 FDA Unclassified (pre-2012) ·initiated 24 Nov 2009
  • Terminated Z-0700-2010 FDA Unclassified (pre-2012) ·initiated 24 Nov 2009
  • Terminated Z-0696-2010 FDA Unclassified (pre-2012) ·initiated 24 Nov 2009
  • Terminated Z-0699-2010 FDA Unclassified (pre-2012) ·initiated 24 Nov 2009
  • Terminated Z-0701-2010 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 used. This requires a new set to be obtained, thus creating a potential for delay in therapy.

510(k) Number

K931377 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Safeline System Turn Lock Cannula

  Class II

  FDA 510(k) K941244 Active Cleared 29 Nov 1994

• Horizon Pump Y-Type Blood Set Open recall

  Class II

  FDA 510(k) K922637 Active Cleared 4 Jun 1993

• Tpn Fluid Transfer Set

  Class II

  FDA 510(k) K905201 Active Cleared 2 Jan 1991

• Intravascular Administration Set

  Class II

  FDA 510(k) K932165 Active Cleared 13 Apr 1994

• Millennium Crt Infusion Pump and Millennium Crt Infusion Pump Administration Sets

  Class II

  FDA 510(k) K972678 Active Cleared 7 Oct 1997

• Intervascular Adminstration Set

  Class II

  FDA 510(k) K911753 Active Cleared 24 Jun 1991

See all devices from Mcgaw, Inc. →