FDA-Device2020-02-05Class II
Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit
Custom Healthcare Systems, Inc.
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.
Sold states
US Distribution to IL.
Affected count
240 kits
Manufactured in
4205 Eubank Rd, N/A, Richmond, VA, United States
Products
Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0863-2020Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief