# FDA recall Z-2823-2018

> **Merit Medical Systems, Inc.** · Class II · device recall initiated 2017-12-20.

## 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 for recall

Mix-up between adult and pediatrics PD catheter.

## 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

## Key facts

- **Recall number:** Z-2823-2018
- **Recalling firm:** Merit Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-20
- **Report date:** 2018-08-22
- **Termination date:** 2020-10-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** South Jordan, UT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2823-2018

## Citation

> AI Analytics. FDA recall Z-2823-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-2823-2018. Source: US FDA. Licensed CC0.

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