# FDA recall Z-2797-2017

> **Sorin Group USA, Inc.** · Class II · device recall initiated 2017-06-29.

## Product

NON-STERILE SAMPLE, SORIN GROUP, SMART CARDIOPLEGIA, CARDIOPLEGIA PACK, REF 627366901, 1 EA, NOT FOR CLINICAL USE

## Reason for recall

Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter).  The result is a potential sterile barrier breach in the display sets. These display sets are  included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-2797-2017
- **Recalling firm:** Sorin Group USA, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-29
- **Report date:** 2017-08-09
- **Termination date:** 2021-04-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Arvada, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2797-2017

## Citation

> AI Analytics. FDA recall Z-2797-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2797-2017. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*