# FDA recall Z-1314-2018

> **Terumo Cardiovascular Systems Corp** · Class II · device recall initiated 2017-12-18.

## Product

Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filters.    The Cardiovascular Procedure Kit containing the Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filter for Exh¿acorporeal Service is indicated for use only in the exh¿acorporeal circuit for cardiopulmonary bypass procedures for which the user designed it. The product is a sterile, disposable kit, intended for one time use for period up to 6 hours, after which it must be discarded in a manner which is within acceptable laws and practices. The Pall LG6NS LeukoGuard ¿ Leukocy1e Reduction Arterial Blood Filter for Exh¿acorporeal Service is designed to reduce the levels of circulating leucocy1es and exclude microemboli greater than 40 ¿m in size from the perfu sate during exh¿acorporea l circulation. This included gas emboli, fat emboli and aggregates composed of platelets, red blood cells and other debris. The Pall LG6NS LeukoGuard ¿ Leukocyte Reduction Arterial B

## Reason for recall

Possible blood leaks through the hydrophobic portion of the Pall LG6NS LeukoGuard Leukocyte Reduction Arterial Blood Filters.

## Distribution

US Distribution to the states of : AL, OH, VA, NC, GA, NY, FL

## Key facts

- **Recall number:** Z-1314-2018
- **Recalling firm:** Terumo Cardiovascular Systems Corp
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-18
- **Report date:** 2018-04-18
- **Termination date:** 2019-04-09

- **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-1314-2018

## Citation

> AI Analytics. FDA recall Z-1314-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1314-2018. Source: US FDA. Licensed CC0.

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