FDA Device recall Z-1144-2018
Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # K14…
- FDA Device
- Class II
- terminated
- Published 2018-03-28
On 2018-03-28 the FDA classified a Class II recall of Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # K14… by Merit Medical Systems, citing 2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product and placed into these dialysis kits.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1144-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-09-20 |
| Published | 2018-03-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Merit Medical Systems |
| Distribution | n/a |
Product
Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # K14-00079
Reason
2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product and placed into these dialysis kits.
Identifiers
| code_info | 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1144-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.