FDADecember 20, 2019device

Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

A component (1961 TELFA PAD 2 X 3) contains LATEX and was used in the Medical Convenience Kit(PAK-19244). Case label and device label for product did NOT show that the Medical Convenience Kit contained LATEX.

What to do

FDA enforcement status: Terminated

Brands named

custom healthcare systemscustomcustom healthcare

UPCs

00811870033261

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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