# FDA recall Z-2550-2018

> **Terumo Cardiovascular Systems Corp** · Class II · device recall initiated 2017-05-12.

## Product

Tubing Pack Convenience Kit, Product Code 65217    Product Usage:  Intended for use only in the extracorporeal circuit of the cardiopulmonary bypass procedures for which the user designed it.

## Reason for recall

Kit was labeled with the incorrect Expiration Date of April 30, 2019.

## Distribution

US state of FL

## Key facts

- **Recall number:** Z-2550-2018
- **Recalling firm:** Terumo Cardiovascular Systems Corp
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-05-12
- **Report date:** 2018-08-01
- **Termination date:** 2018-10-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Ashland, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2550-2018

## Citation

> AI Analytics. FDA recall Z-2550-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2550-2018. Source: US FDA. Licensed CC0.

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