Reported Mar 28, 2018 · Terminated
Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 1 Cuff Infant…
Merit Medical 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: Merit Medical Systems, Inc. · 1600 W Merit Pkwy · South Jordan, UT · 84095-2416
Is this the product you have?
- Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # K14-00079
- Lot codes and dates
Lot #: a) H1190448Exp 7/31/2020UDI (01)00884450328620(17)200731(10)H1190448b) H1193585Exp 5/30/2019UDI (01)00884450328620(17)190530(10)H1193585
- Amount recalled
- 44
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Why it was recalled
2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product and placed into these dialysis kits.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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