# FDA recall Z-0817-2018

> **Circulatory Technology Inc** · Class II · device recall initiated 2017-09-22.

## Product

Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, pouched) and BB14NS (sold bulk to kit manufacturers)

## Reason for recall

The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line and cause a drop in circuit blood flow.

## Distribution

**Requested update** Distributed in 19 states: AL, AR, CA, FL, GA, IL, IN, KY, MD, MO, NJ, NY, OH, OR, PA, TN, TX, VA, WA, and the District of Columbia.

## Key facts

- **Recall number:** Z-0817-2018
- **Recalling firm:** Circulatory Technology Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-09-22
- **Report date:** 2018-03-07
- **Termination date:** 2020-05-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Oyster Bay, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0817-2018

## Citation

> AI Analytics. FDA recall Z-0817-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0817-2018. Source: US FDA. Licensed CC0.

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