medical Class II Updated 2020-02-05

Custom Healthcare Systems, Inc. recalls Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-1

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Affected States: IL
Lot/Code Info: LOT NUMBER: 20190614, expires February 1, 2020 UNIQUE DEVICE IDENTIFIER: (01)00811870033261(17)200201(10)20190614
View official government recall

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