# FDA recall Z-1663-2019

> **Maquet Cardiovascular, LLC** · Class II · device recall initiated 2019-04-18.

## Product

Maquet Getinge-  (1)Material: 701065765R01	BO-TOP 36504 Adult ECC Pack  (2)Material: 701065765R02	BO-TOP 36504 Adult ECC Pack

## Reason for recall

Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-1663-2019
- **Recalling firm:** Maquet Cardiovascular, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-04-18
- **Report date:** 2019-06-05
- **Termination date:** 2025-07-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wayne, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1663-2019

## Citation

> AI Analytics. FDA recall Z-1663-2019. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-1663-2019. Source: US FDA. Licensed CC0.

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