# FDA recall Z-1119-2020

> **LivaNova USA Inc.** · Class III · device recall initiated 2019-01-28.

## Product

LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOnly, (01)04033817901594    Product Usage:  The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.

## Reason for recall

Incorrect labeling; it was identified that some Datapad devices contained incorrect labels. Specifically the manufacturing date in the production identifier was incorrect and the manufacturing date on the unique device identifier  label was labeled  in the format of yy-mm-dd instead of yyyy-mm-dd.

## Distribution

US: NJ and CA

## Key facts

- **Recall number:** Z-1119-2020
- **Recalling firm:** LivaNova USA Inc.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-01-28
- **Report date:** 2020-02-19
- **Termination date:** 2022-01-31

- **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-1119-2020

## Citation

> AI Analytics. FDA recall Z-1119-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1119-2020. Source: US FDA. Licensed CC0.

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