FDASeptember 20, 2017device

Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 2 Cuffs Infant Coiled, Catalog # K14-00078

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

1 Cuff catheters were incorrectly configured and labeled as 2 Cuff product and placed into these dialysis kits.

What to do

FDA enforcement status: Terminated

Brands named

merit medical systemsmeritmerit medical

UPCs

00884450328613

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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