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MED3272
ENTHERMICS, INC. · Model MED3272 · UDI-DI 00851962007725
10
510(k) clearances
211
Adverse events
10
Recalls
31
Facilities
Description
15.4 cu ft irrigation fluid warmer
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-10-25 | Smiths Medical ASD, Inc. | Smiths Medical became aware that that one (1) NORMOFLO H-1100 Irrigation Fluid Warmers was incorrectly labelled with Spanish language labels instead of English labels. Specifical |
| 2015-08-25 | Resource Optimization & Innovation Llc | Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance. |
| 2015-08-25 | Resource Optimization & Innovation Llc | Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance. |
| 2015-08-25 | Resource Optimization & Innovation Llc | Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance. |
| 2015-08-25 | Resource Optimization & Innovation Llc | Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance. |
| 2015-08-25 | Resource Optimization & Innovation Llc | Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance. |
| 2015-08-25 | Resource Optimization & Innovation Llc | Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance. |
| 2015-08-25 | Resource Optimization & Innovation Llc | Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance. |
| 2015-08-25 | Resource Optimization & Innovation Llc | Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance. |
| 2015-08-18 | Ecolab Inc | The sterile packaging may contain small (less than 250 microns wide) channels in the seal of the pouch. If channels are present, the package integrity is compromised and there is a |
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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.