Custom Healthcare Systems, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0863-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 20, 2019

Date Posted: February 5, 2020

Recall Number: Z-0863-2020

Event ID: 84693

Reason for Recall:

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.

Status: Terminated

Product Quantity: 240 kits

Code Information:

LOT NUMBER: 20190614, expires February 1, 2020 UNIQUE DEVICE IDENTIFIER: (01)00811870033261(17)200201(10)20190614

Distribution Pattern:

US Distribution to IL.

Voluntary or Mandated:

Voluntary: Firm initiated