FDA Device recall Z-2823-2018
Flex-Neck Classic Peritoneal Dialysis Catheter (Pediatric) Product Usage: If the patient is a suitable candidate for peritoneal dialysis (P…
- FDA Device
- Class II
- terminated
- Published 2018-08-22
On 2018-08-22 the FDA classified a Class II recall of Flex-Neck Classic Peritoneal Dialysis Catheter (Pediatric) Product Usage: If the patient is a suitable candidate for peritoneal dialysis (P… by Merit Medical Systems, citing mix-up between adult and pediatrics PD catheter.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2823-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-20 |
| Published | 2018-08-22 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Merit Medical Systems |
| Distribution | US |
Product
Flex-Neck Classic Peritoneal Dialysis Catheter (Pediatric) Product Usage: If the patient is a suitable candidate for peritoneal dialysis (PD) therapy, The Flex-Neck¿ PD Catheter can be implanted either surgically or peritoneoscopically. The only contraindication to implantation of the FlexNeck PD Catheter is if the patient is not a candidate for peritoneal dialysis. Numerous prior surgeries or suspected or documented intraperitoneal adhesions may be relative contraindications to PD. However, since the Y-TEC¿ System of peritoneoscopic implantation enable inspection of the peritoneum to confirm the presence of adhesions and to avoid them, all patients who are suitable for PD can receive this catheter.
Reason
Mix-up between adult and pediatrics PD catheter.
Identifiers
| code_info | Catalog Number: CF-5242 Lot Numbers: H1027245, H1038032, H1040946, H1063581, H1082840, H1117442, H845164, H879797, H936407, H980897, and H995076. |
|---|
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-2823-2018%22
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