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Preemie Transport Blanket

Bionix, LLC · Model 1126 · UDI-DI 00714646000484

KME Prescription
10
510(k) clearances
69
Adverse events
2
Recalls
581
Facilities

Description

Preemie Transport Blanket, Very Low Birth Weight Blankets - 15ct

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.