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Pedigo Products, Inc.
PEDIGO PRODUCTS, INC. · Model DC400L-220-230V-TYPE-G · UDI-DI 00841027101239
1
510(k) clearances
6,999
Adverse events (48 deaths)
33
Recalls
72
Facilities
Description
COMFORT400L, 220/230V, 50/60 HZ RHWD. TYPE G
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.