Home › Device types › LGZ
Warmer, Thermal, Infusion Fluid
FDA product code LGZ · Class 2 · General Hospital
582
Registered devices
6,999
Adverse events
33
Recalls
75
510(k) clearances
Devices with this code
QIF-01-12 extended kit — QUALITY IN FLOW LTDPedigo Products, Inc. — PEDIGO PRODUCTS, INC.Pedigo Products, Inc. — PEDIGO PRODUCTS, INC.Warming Cabinet Single Compartment (SS Door) — Imperial Surgical LtdenFlow — Carefusion CorporationPedigo Products, Inc. — PEDIGO PRODUCTS, INC.Pedigo Products, Inc. — PEDIGO PRODUCTS, INC.Dutch, Rapid Infuser RI-2, 230V, 750 ml/min — BELMONT INSTRUMENT CORPORATIONPedigo Products, Inc. — PEDIGO PRODUCTS, INC.Pedigo Products, Inc. — PEDIGO PRODUCTS, INC.Pedigo Products, Inc. — PEDIGO PRODUCTS, INC.Pedigo Products, Inc. — PEDIGO PRODUCTS, INC.Pedigo Products, Inc. — PEDIGO PRODUCTS, INC.Italian, Rapid Infuser, 230 V, 1000ml/min — BELMONT INSTRUMENT CORPORATIONFluido® AirGuard System — The Surgical Company International B.V.Warming Cabinet Double Compartment (Glass Door) — Imperial Surgical LtdItalian, Hyperthermia Pump, 230V — BELMONT INSTRUMENT CORPORATIONPedigo Products, Inc. — PEDIGO PRODUCTS, INC.Fluid Replacement Supply — BELMONT INSTRUMENT CORPORATIONUK, Rapid Infuser RI-2, 230V, 1000 ml/min — BELMONT INSTRUMENT CORPORATIONMEDIVNEXT — ENTHERMICS, INC.Life Warmer Quantum Blood and Fluid Warming System — NORTH AMERICAN RESCUE, LLCStraight In/Bifurcated Out Pt Line (1 Piece) — BELMONT INSTRUMENT CORPORATIONAmsco — STERIS CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-24 | ICU Medical Inc. | 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 applica |
| 2025-04-22 | 3M Company | Notice was issued to clarify flow rates related to the inlet fluid temperature. |
| 2025-03-31 | Belmont Instrument LLC | Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid |
| 2025-03-31 | Belmont Instrument LLC | Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid |
| 2025-03-31 | Belmont Instrument LLC | Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid |
| 2025-03-31 | Belmont Instrument LLC | Potential crack in the female connector located on the Heat Exchanger/patient line set, which will lead to a fluid leak through the crack during priming of the |
| 2021-08-06 | Smiths Medical ASD Inc. | There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer duration of use. |
| 2021-08-06 | Smiths Medical ASD Inc. | There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer duration of use. |
| 2021-06-04 | Eight Medical International BV | The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions. |
| 2021-04-30 | RanD S.r.l. | The sterilization contractor informed the company of a quality issue possibly affecting the sterilization process of a certain number of products. It was deter |
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