Reported Feb 5, 2020 · Terminated

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

Custom Healthcare Systems, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Custom Healthcare Systems, Inc. · 4205 Eubank Rd · Richmond, VA · 23231-4328

Is this the product you have?

  • Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit
Lot codes and dates
  • LOT NUMBER
    • 20190614
    • expires February 1
    • 2020
  • UNIQUE DEVICE IDENTIFIER(01)00811870033261(17)200201(10)20190614
Amount recalled
240 kits

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 1, 2022 · Data as of Sep 19, 5:27 PM UTC

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