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Thermoflect
Encompass Group, L.L.C. · Model 5170-200 · UDI-DI 20612899001057
KME
Prescription
10
510(k) clearances
64
Adverse events
2
Recalls
581
Facilities
Description
THERMOFLECT COCOON, UNIV, 10EA TS THERMOFLECT COCOON, ADULT, SILVER, 1/BG, 10 BG/CS NW
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.