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Hotline Fluid Warmer

by Level 1 Technologies, Inc.

510(k) K911383

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK911383 Date17 Oct 1991ClearedStatusActive

Recalls

11 recalls · 1 ongoing · FDA

    • Ongoing Z-2759-2026 FDA Class II initiated 24 Jun 2026

    ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent application at the tubing to return connector bond.

    • Terminated Z-1443-2014 FDA Class II initiated 17 Mar 2014

    Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged.

    • Terminated Z-1444-2014 FDA Class II initiated 17 Mar 2014

    Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged

    • Terminated Z-1979-2012 FDA Class II initiated 27 Jun 2012

    HOTLINE 3 Blood and Fluid Warmer( Reorder No. HL-390 ) disposable is not correctly installed , the microswitch may become damaged and unusable

  • 7 recalls, same reason

    • Terminated Z-0424-2012 FDA Unclassified (pre-2012) initiated 21 Nov 2011
    • Terminated Z-0427-2012 FDA Unclassified (pre-2012) initiated 21 Nov 2011
    • Terminated Z-0422-2012 FDA Unclassified (pre-2012) initiated 21 Nov 2011
    • Terminated Z-0423-2012 FDA Unclassified (pre-2012) initiated 21 Nov 2011
    • Terminated Z-0428-2012 FDA Unclassified (pre-2012) initiated 21 Nov 2011
    • Terminated Z-0425-2012 FDA Unclassified (pre-2012) initiated 21 Nov 2011
    • Terminated Z-0426-2012 FDA Unclassified (pre-2012) initiated 21 Nov 2011

    Disconnected/ loose Luer connectors at the patient end of the triple lumen tubing of the HOTLlNE Disposable Administration Sets and Level 1 D/DI-60HL Normothermic IV Administration Sets

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LGZ
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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