FDA recall Z-0863-2020

Product

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

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.

Distribution

US Distribution to IL.

Key facts

Status

Terminated

Initiation date

2019-12-20

Report date

2020-02-05

Termination date

2022-08-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Richmond, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0863-2020