# FDA recall Z-2569-2024

> **Merit Medical Systems, Inc.** · Class II · device recall initiated 2024-06-11.

## Product

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes:    PC (Pericardiocentesis Tray - Fluid drainage tray), REF:  PC101/B  PC801  PC801/A  PC802  PC802/A    The Pericardiocentesis Kit is intended to withdraw fluid from the pericardial sac (membrane surrounding the heart) to evaluate the fluid for diagnostic purposes or to remove excess fluid causing compression of the heart.

## Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

## Distribution

U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.

## Key facts

- **Recall number:** Z-2569-2024
- **Recalling firm:** Merit Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-06-11
- **Report date:** 2024-08-21

- **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-2569-2024

## Citation

> AI Analytics. FDA recall Z-2569-2024. Retrieved 2026-07-28 from https://api.ai-analytics.org/recall/Z-2569-2024. Source: US FDA. Licensed CC0.

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