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Thermoflect
Encompass Group, L.L.C. · Model 5105-100 · UDI-DI 30612899510518
KME
Prescription
10
510(k) clearances
69
Adverse events
2
Recalls
589
Facilities
Description
THERMOFLECT MITT, UNIV, 50EA TS THERMOFLECT OXIMETER MITT, SILVER, 5/BG, 10 BG/CS NONWVN
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-06-23 | Microtek Medical Inc. | Certain lots of the products have a Naphthalene odor. |
| 2017-12-27 | LITTLE RAPIDS CORPORATION | The secondary supplier provided material was within specification but did not meet our design needs compared to the primary manufacturer. The product is designed for patient trans |
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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.