Level 1
26 catalogue numbers from IR-6, listed by ICU Medical, Inc, United States, under Warmer, Thermal, Infusion Fluid. 1 manufacturer in China is registered for this product code.
1manufacturer
26catalogue numbers in this listing
1recall
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
Record
| Listed by | ICU Medical, Inc, United States |
|---|---|
| FDA product code | LGZ |
| Device type | Warmer, Thermal, Infusion Fluid |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K911383 |
| Record published | 2016-10-14 |
| Record revised | 2025-04-23 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Case of 20, case of 30, case of 40, case of 160, box of 10, box of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IR-6 | In distribution | |
| HL-90 | In distribution | |
| IR-500 | In distribution | |
| IR-600 | In distribution | |
| PL-6 | In distribution | |
| L-370 | In distribution | |
| HL-390-40 | In distribution | |
| IR-700 | In distribution | |
| L-70 | In distribution | |
| H-1100-ES-115V | In distribution | |
| HL-90-40 | In distribution | |
| IR-40 | In distribution | |
| L-270 | In distribution | |
| HL-390 | In distribution | |
| L-70NI | In distribution | |
| L-80 | In distribution | |
| HL-390-38 | In distribution | |
| HL-90-38 | In distribution | |
| YC-8 | In distribution | |
| H-1129 | In distribution | |
| HL-90-SP-115 | In distribution | |
| PL-7 | In distribution | |
| PC-8 | In distribution | |
| IRI-600 | In distribution | |
| IR-7 | In distribution | |
| L-10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pedigo Products, Inc. | Pedigo Products, Inc. | 207 |
| Amsco | Steris Corporation | 38 |
| Skytron warming cabinet | Skytron, LLC | 24 |
| ThermaCor 1200 Infusion System | Smisson-Cartledge Biomedical LLC | 11 |
| Astoflo® Plus ECO | Stihler Electronic Gmbh | 10 |
| enFlow | Carefusion | 8 |
| Fluido® AirGuard System | The Surgical Company International B.V. | 7 |
| Smithworks Medical, Inc. | Smithworks, Inc. | 5 |
| Warming Cabinet Single Compartment Counter-Top Model (Glass Door) | Imperial Surgical Ltd. | 4 |
| Hang&Go PAC | Rand SPA | 4 |
| enFlow™ | Airlife, Inc. | 4 |
| Enteral Feeding | Medela LLC | 4 |
Showing 12 of 159. All products under Warmer, Thermal, Infusion Fluid
Recalls Naming This Product
11 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| ICU Medical, Inc | 510(k) number | 2026-06-24 | Class II | Process control | 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. | 39,750 units | |
| Smiths Medical Asd, Inc. | 510(k) number | 2014-03-17 | Class II | Nonconforming Material/Component | Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged. | 393,210 | 2015-06-09 |
| Smiths Medical Asd, Inc. | 510(k) number | 2014-03-17 | Class II | Nonconforming Material/Component | Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged | 870 units | 2015-06-09 |
| Smiths Medical Asd, Inc. | 510(k) number | 2012-06-27 | Class II | Device Design | HOTLINE 3 Blood and Fluid Warmer( Reorder No. HL-390 ) disposable is not correctly installed , the microswitch may become damaged and unusable | 2247 units | 2014-02-20 |
| Smiths Medical Asd, Inc. | 510(k) number | 2011-11-21 | Not classified | Device Design | 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 | 449,307 sets | 2014-08-07 |
| Smiths Medical Asd, Inc. | 510(k) number | 2011-11-21 | Not classified | Device Design | 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 | 245,939 units | 2014-08-07 |
| Smiths Medical Asd, Inc. | 510(k) number | 2011-11-21 | Not classified | Device Design | 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 | 60,084 units | 2014-08-07 |
| Smiths Medical Asd, Inc. | 510(k) number | 2011-11-21 | Not classified | Device Design | 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 | 36,421 units | 2014-08-07 |
| Smiths Medical Asd, Inc. | 510(k) number | 2011-11-21 | Not classified | Device Design | 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 | 3062 units | 2014-08-07 |
| Smiths Medical Asd, Inc. | 510(k) number | 2011-11-21 | Not classified | Device Design | 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 | 3062 units | 2014-08-07 |
| Smiths Medical Asd, Inc. | 510(k) number | 2011-11-21 | Not classified | Device Design | 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 | 7631 units | 2014-08-07 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.