# FDA recall Z-1486-2021

> **Cardiac Assist, Inc** · Class II · device recall initiated 2021-03-19.

## Product

Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization.   Catalog #: 5840-2417 - LS Tandem Life Kit - V24/A17  Catalog #: 5840-2415 - LS Tandem Life Kit - V24/A15  Catalog #: 5740-2417 - TandemLife Kit - V24/A17  Catalog #: 5100-1422 - ProtekSolo Venous Dilator Set (14-22 Fr)

## Reason for recall

On 02/26/2021, it was found that there were incorrectly packaged Dilator sets in Finished Goods. On 03/1/2021, it was confirmed that 14 kits containing the impacted products had been distributed to the field.

## Distribution

US Nationwide distribution in the states of AL, AZ, IL, TN.

## Key facts

- **Recall number:** Z-1486-2021
- **Recalling firm:** Cardiac Assist, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-19
- **Report date:** 2021-05-05
- **Termination date:** 2021-11-22

- **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-1486-2021

## Citation

> AI Analytics. FDA recall Z-1486-2021. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-1486-2021. Source: US FDA. Licensed CC0.

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