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Alleset

GRI Medical & Electronic Technology Co., Ltd. · Model 68-480001 · UDI-DI 16931918179940

KME
10
510(k) clearances
69
Adverse events
2
Recalls
584
Facilities

Description

Thermuff bag_25ea/cs

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.