Class II — Merit Medical Systems, Inc.
| Recalling firm | Merit Medical Systems, Inc. |
|---|---|
| Registered facility | View this company's 15 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Mix-up between adult and pediatrics PD catheter. |
| 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 conf… |
| Distribution | Worldwide Distribution - US Nationwide in the states of AL, CA, DE, FL, KY, MA, MO, NC, NY, OH, PA, and UT and the countries of Germany |
| Initiated | 2017-12-20 |
| Classified | 2018-08-14 |
| Terminated | 2020-10-29 |
| Recall number | Z-2823-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Merit Medical Systems, Inc. (Z-2823-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80651/
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