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Thermoflect

Encompass Group, L.L.C. · Model 5000-800 · UDI-DI 00612899004108

FME Prescription
5
510(k) clearances
8
Adverse events (1 deaths)
1
Recalls
237
Facilities

Description

THERMOFLECT GOWN KIT A, 25 EA TS THERMOFLECT GOWN KIT A, GOWN, CAP, PSFW,1 BEL BG, 25EA NW

Recalls

DateFirmReason
2009-12-23Encompass Group LLCThe products are not compatible for use in the Magnetic Resonance Imaging (MRI) environment.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data 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.