# FDA recall Z-0311-2022

> **Cardiac Assist, Inc** · Class III · device recall initiated 2021-10-14.

## Product

SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following components: a) 31 Fr ProtekDuo Veno-Venous Cannula Set b) LifeSPARC Pump c) 14Fr to 26 Fr Dilator Set d) TandemHeart Wrap.  Kit Number: 5820-3118  Intended use is applicable to the intended use of specific devices included in the kit.

## Reason for recall

Top label of the outer package of the collection kit Item 5820-3118 showed expiration date of 2022/05/01 (correct expiration date) while side label showed expiration date of 2021/05/01 (incorrect expiration date)

## Distribution

US Distribution to states of: DC, MA, SC, and VA.

## Key facts

- **Recall number:** Z-0311-2022
- **Recalling firm:** Cardiac Assist, Inc
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-10-14
- **Report date:** 2021-12-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pittsburgh, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0311-2022

## Citation

> AI Analytics. FDA recall Z-0311-2022. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0311-2022. Source: US FDA. Licensed CC0.

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