Food, drugs, devices › Merit Medical Systems, Inc.
Device recall: Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # CF-4235/B
FDA enforcement event 79426 is a device recall by Merit Medical Systems, Inc. of South Jordan, UT, initiated 20 Sep 2017 and classified Class II, with 3 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated. Initiation: voluntary: firm initiated. Merit Medical Systems, Inc. has 59 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Merit Medical Systems, Inc., South Jordan, UT.
Reason for recall
"2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product and placed into these dialysis kits."
Distribution
"United States, Austria, Finland, Germany, Ireland, Switzerland, and United Kingdom"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1143-2018 | Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # CF-4235/B | 30 | Class II | Terminated | 28 Mar 2018 |
| 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 | 44 | Class II | Terminated | 28 Mar 2018 |
| 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 | 8 | Class II | Terminated | 28 Mar 2018 |
Context
Other enforcement events for Merit Medical Systems, Inc.
All 59 events for Merit Medical Systems, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product and placed into these dialysis kits."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "United States, Austria, Finland, Germany, Ireland, Switzerland, and United Kingdom"
Is the recall still ongoing?
FDA lists the status as Terminated. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.