# FDA recall Z-1728-2018

> **Datascope Corporation** · Class II · device recall initiated 2017-10-19.

## Product

BEQ-TOP 22301, Custom Tubing Kit, Catalog No. 701049513

## Reason for recall

The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow.

## Distribution

Distributed to accounts in AL, AR, CA, DC, FL, IL, LA, MO, NC, PA, SC, TX, and WA.

## Key facts

- **Recall number:** Z-1728-2018
- **Recalling firm:** Datascope Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-19
- **Report date:** 2018-05-16
- **Termination date:** 2020-04-24

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1728-2018

## Citation

> AI Analytics. FDA recall Z-1728-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1728-2018. Source: US FDA. Licensed CC0.

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