# FDA recall Z-2329-2024

> **Cardinal Health 200, LLC** · Class II · device recall initiated 2024-05-29.

## Product

Presource kits and trays, labeled as:   1) Cardiovascular Procedure Kit, Catalog Number SAN29ANCC3;  2) Cardiovascular Procedure Kit, Catalog Number SAN29ANCC4;  3) Cardiovascular Procedure Kit, Catalog Number SAN29ANCCL;  4) Cardiovascular Procedure Kit, Catalog Number SAN29ANCCM;  5) Cardiovascular Procedure Kit, Catalog Number SAN33CDCAS;  6) Cardiovascular Procedure Kit, Catalog Number SAN33CDCAT;  7) Cardiovascular Procedure Kit, Catalog Number SANOCAENSA;  8) Cardiovascular Procedure Kit, Catalog Number SCV29ANCCA;  9) Left Heart Kit, Catalog Number  SAN73LHKCC;  10) Left Heart Kit, Catalog Number SAN73LHKC6

## Reason for recall

Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical¿ supplied finished kits. Merit Medical¿ supplied finished kits are included as components in Presource kits. According to the FDA s communication, these Shenli syringes, located inside a Merit Medical¿ kit component, cannot be distributed for use as they could contain a significant change or modification in design which could significantly alter the safety or effectiveness of the finished kit product, resulting in the risk of patient harm such as inaccurate dosing and a leaking device.

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-2329-2024
- **Recalling firm:** Cardinal Health 200, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-05-29
- **Report date:** 2024-07-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waukegan, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2329-2024

## Citation

> AI Analytics. FDA recall Z-2329-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2329-2024. Source: US FDA. Licensed CC0.

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