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QIF-01-12 extended kit
QUALITY IN FLOW LTD · Model QIF-01-12 · UDI-DI 07290016740097
10
510(k) clearances
7,003
Adverse events (48 deaths)
33
Recalls
72
Facilities
Description
QinFlow Warrior Extreme system kit - the QiF warmer is a portable, inline blood and fluid warmer system. The QiF Blood and Fluid Warmer is located between the fluid container (intravenous fluid, blood or blood product) and treated patient, outside of the patient’s body. The kit contains 2 batteries. The S/N of the kit is identical to the S/N of the Base Unit inside the kit.
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 application at the tubing t |
| 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 infuser. |
| 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 Rapid Infuser. |
| 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 infuser. |
| 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 infuser. |
| 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 determined that some lots |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.