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Elite Mylar Blanket

MEDSOURCE INTERNATIONAL LLC · Model ELITE-B100 · UDI-DI 00816703023228

KME
10
510(k) clearances
69
Adverse events
2
Recalls
589
Facilities

Description

Elite Mylar Blanket / Elite First Aid Part Number: 700

Recalls

DateFirmReason
2023-06-23Microtek Medical Inc.Certain lots of the products have a Naphthalene odor.
2017-12-27LITTLE RAPIDS CORPORATIONThe 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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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.