Merit Medical Custom Dialysis Kit CF-4235: Incorrect Cuff Count Risk
Merit Medical recalls Custom Dialysis Kit CF-4235 Without Gel due to incorrect cuff labeling. This may cause improper dialysis setup. Affected units include specific lot numbers and expiration dates.
Lower-risk recall
2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product and placed into these dialysis kits.
Contact the company
What happened, in plain English
Merit Medical is recalling Custom Dialysis Kit CF-4235 Without Gel because it includes two 1-cuff catheters labeled as one-cuff products. This could lead to improper dialysis setup if used without correction. Read more at govinfonow.com/recall/72970-merit-medical-custom-dialysis-kit-cf-4235-incorrect-cuff-count.
Source Summary by GovInfoNow · govinfonow.com/recall/72970-merit-medical-custom-dialysis-kit-cf-4235-incorrect-cuff-count · Updated September 17, 2026 · FDA enforcement record: FDA #Z-1144-2018
Cite this page
“Merit Medical Custom Dialysis Kit CF-4235: Incorrect Cuff Count Risk.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/72970-merit-medical-custom-dialysis-kit-cf-4235-incorrect-cuff-count. Based on FDA recall #Z-1144-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1144-2018%22&limit=1).
Why it’s dangerous
The kit contains two 1-cuff catheters but is labeled as one-cuff. This mismatch could cause improper dialysis setup if not corrected, potentially affecting treatment effectiveness.
Who’s affected
Infants using peritoneal dialysis with this specific kit model. Healthcare providers who administer dialysis to infants are most at risk.
How to tell if you have this one
Check for the kit model CF-4235 Without Gel. Look for lot numbers H1190448 (exp 7/31/2020) or H1193585 (exp 5/30/2019) on the packaging.
- Brand
Merit Medical Systems- Product
Merit Medical Systems, Inc. recalls Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 1 Cuff Infant- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
United States, Austria, Finland, Germany, Ireland, Switzerland, and United Kingdom
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1143-2018 | Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # CF-4235/B; Lot #: a) H1136644, Exp 12/31/2018, UDI (01)00884450305850(17)181231(10)H1136644; b) H1139640, Exp 12/31/18, UDI (01)00884450305850(17)181231(10)H1139640 | 30 |
| Z-1144-2018 | Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # K14-00079; Lot #: a) H1190448, Exp 7/31/2020, UDI (01)00884450328620(17)200731(10)H1190448; b) H1193585, Exp 5/30/2019, UDI (01)00884450328620(17)190530(10)H1193585 | 44 |
| Z-1145-2018 | Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 2 Cuffs Infant Coiled, Catalog # K14-00078; Lot #: H1190932, Exp 7/31/2020, UDI (01)00884450328613(17)200731(10)H1190932 | 8 |
What to do — step by step
Check Kit Model
Verify the kit model is CF-4235 Without Gel with the specific lot numbers listed in the recall.
How this recall unfolded
Recall timeline
FDA published this recall 6 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1144-2018 (September 20, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1144-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.