510(k) K911383 ยท LGZ Warmer, Thermal, Infusion Fluid
HOTLINE FLUID WARMER
| Applicant | Level 1 Technologies, Inc., Potomac MD, US |
| Decision | Substantially Equivalent, Oct 17, 1991 |
| Received | Mar 28, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911383
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 17, 2026 | ICU Medical Inc. Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow Open, Classified |
LGZ | None listed |
| Apr 9, 2014 | Smiths Medical ASD, Inc. Smiths Medical HOTLINE Fluid Warming Set L-70.
Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions Terminated |
LGZ | None listed |
| Apr 9, 2014 | Smiths Medical ASD, Inc. Smiths Medical HOTLINE Fluid Warming Set L-80.
Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity
conditions Terminated |
LGZ | None listed |
| Jul 9, 2012 | Smiths Medical ASD, Inc. Smiths Medical HOTLINE 3 Blood and Fluid Warmer,
Reorder Numbers: HL-390
Product Usage:
The Micro-switch is used on the HOTLINE 3 Blood and Fluid Warmer. This product, for use in conjunction with HOT Terminated |
LGZ | None listed |
| Jan 11, 2012 | Smiths Medical ASD, Inc. HOTLlNE Disposable Administration Sets, Product Codes L-70
Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE Routine Flow Blood an Terminated |
LGZ | None listed |
| Jan 11, 2012 | Smiths Medical ASD, Inc. HOTLlNE Disposable Administration Sets, Product Codes L-70NI
Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE Routine Flow Blood Terminated |
LGZ | None listed |
| Jan 11, 2012 | Smiths Medical ASD, Inc. HOTLlNE Disposable Administration Sets,
Product Code L-270
Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE Routine Flow Blood a Terminated |
LGZ | None listed |
| Jan 11, 2012 | Smiths Medical ASD, Inc. HOTLlNE Disposable Administration Sets,
Product Code L-370
Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE Routine Flow Blood a Terminated |
LGZ | None listed |
| Jan 11, 2012 | Smiths Medical ASD, Inc. HOTLlNE Disposable Administration Sets,
Product Code L-80
Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE Routine Flow Blood an Terminated |
LGZ | None listed |
| Jan 11, 2012 | Smiths Medical ASD, Inc. Level 1 Normothermic I.V. Fluid Administration Sets,
Product Code D-60HL ,
Product Usage: Single patient use sets designed for use by trained medical professionals, in conjunction with Level 1 Fast Terminated |
LGZ | None listed |
| Jan 11, 2012 | Smiths Medical ASD, Inc. Level 1 Normothermic I.V. Fluid Administration Sets,
Product Code DI-60HL ,
Product Usage: Single patient use sets designed for use by trained medical professionals, in conjunction with Level 1 Fast Terminated |
LGZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.