---
title: "SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary by... — FDA record Z-0311-2022 | Is It on Recall"
description: "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 expir"
url: https://isitonrecall.com/recall/fda-device-z-0311-2022-ship-kit-procedure-kit-protekduo-ls-dl31-for-temporary-cardiopulmonary-bypass-including-the-followin/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following components... — FDA record Z-0311-2022

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 14, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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**: 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)
- **Classification**: Class III
- **Recalling firm**: Cardiac Assist, Inc
- **Quantity**: 7 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0311-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0311-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Serial Numbers: 872170, 872171, 872172, 872173, 872182, 872183, 872184. UDI: 01)00814112020791(17)220 501(22)220511(21) 872170; (01)00814112020791(17)220 501(22)220511(21) 872171; (01)00814112020791(17)220 501(22)220511(21) 872172; (01)00814112020791(17)220 501(22)220511(21) 872173; (01)00814112020791(17)220 501(22)220511(21) 872182; (01)00814112020791(17)220 501(22)220511(21) 872183; 01)00814112020791(17)220 501(22)220511(21) 872184 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [District of Columbia](https://isitonrecall.com/state/district-of-columbia/)
- [Massachusetts](https://isitonrecall.com/state/massachusetts/)
- [South Carolina](https://isitonrecall.com/state/south-carolina/)
- [Virginia](https://isitonrecall.com/state/virginia/)

## Dates in the source

- **Report date**: Dec 8, 2021
- **Recall initiation date**: Oct 14, 2021
- **Center classification date**: Nov 29, 2021

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0311-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Cardiac Assist, Inc records](https://isitonrecall.com/brand/cardiac-assist-inc/)