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Is the Custom Dialysis Kit CF-4230 Without Gel, which includes… safe?

Merit Medical Systems, Inc. · Recalled Sep 20, 2017
No — the Custom Dialysis Kit CF-4230 Without Gel, which includes… was recalled on Sep 20, 2017 due to a safety issue. 1 Cuff catheters were incorrectly configured and labeled as 2 Cuff product and placed into these dialysis kits. If you have this product: Stop using this product and follow the manufacturer's recall instructions for a refund or replacement. Contact your pediatrician if your baby was exposed and shows any symptoms.
Why it was recalled
1 Cuff catheters were incorrectly configured and labeled as 2 Cuff product and placed into these dialysis kits.
What to do
Stop using this product and follow the manufacturer's recall instructions for a refund or replacement. Contact your pediatrician if your baby was exposed and shows any symptoms.
View the official FDA recall →
This is an official recall published by FDA. Recall details are current as of 2026-06-25; verify the latest status at the source.

Custom Dialysis Kit CF-4230 Without Gel, which includes…: common questions

Is the Custom Dialysis Kit CF-4230 Without Gel, which includes… safe?
No. The Custom Dialysis Kit CF-4230 Without Gel, which includes… was recalled on Sep 20, 2017 due to a safety issue. 1 Cuff catheters were incorrectly configured and labeled as 2 Cuff product and placed into these dialysis kits.
Has the Custom Dialysis Kit CF-4230 Without Gel, which includes… been recalled?
Yes. The Custom Dialysis Kit CF-4230 Without Gel, which includes… was recalled on Sep 20, 2017. The recall was issued by FDA (recall ID Z-1145-2018).
Why was the Custom Dialysis Kit CF-4230 Without Gel, which includes… recalled?
1 Cuff catheters were incorrectly configured and labeled as 2 Cuff product and placed into these dialysis kits.
What should I do if I have the Custom Dialysis Kit CF-4230 Without Gel, which includes…?
Stop using this product and follow the manufacturer's recall instructions for a refund or replacement. Contact your pediatrician if your baby was exposed and shows any symptoms.
Where can I find the official recall notice for the Custom Dialysis Kit CF-4230 Without Gel, which includes…?
The official FDA recall record is available here. Always verify recall details with the official source.

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