CLASS II Device recall · Reported 28 Mar 2018 · FDA Enforcement Report
Custom Dialysis Kit CF-4230 Without Gel recalled
Merit Medical Systems is recalling Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck¿ Classic Peritoneal. The recall was initiated on 20 Sep 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1145-2018
- FDA event ID
- 79426
- Recalling firm
- Merit Medical Systems, South Jordan, UT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Sep 2017
- FDA classified
- 20 Mar 2018
- Reported
- 28 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 20 Sep 2017 | Recall initiated by company | |
| 20 Mar 2018 | Classified by FDA | +181 days |
| 28 Mar 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
1 Cuff catheters were incorrectly configured and labeled as 2 Cuff product and placed into these dialysis kits.
Product as listed by the FDA
Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 2 Cuffs Infant Coiled, Catalog # K14-00078
Where it was distributed
United States, Austria, Finland, Germany, Ireland, Switzerland, and United Kingdom
Questions about this recall
Is Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck¿ Classic Peritoneal recalled?
Yes. Merit Medical Systems recalled Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck¿ Classic Peritoneal on 20 Sep 2017. The recall is Class II and its status is Terminated. Recall number Z-1145-2018.
Why was it recalled?
1 Cuff catheters were incorrectly configured and labeled as 2 Cuff product and placed into these dialysis kits.
Which lots are affected?
Lot #: H1190932, Exp 7/31/2020, UDI (01)00884450328613(17)200731(10)H1190932
Where was it sold?
United States, Austria, Finland, Germany, Ireland, Switzerland, and United Kingdom
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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