# FDA recall Z-2639-2017

> **DeRoyal Industries Inc** · Class II · device recall initiated 2017-06-07.

## Product

DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO,    Dolphin is an inflation device indicated during angioplasty procedures to inflate and deflate the balloon catheter, and control pressure.

## Reason for recall

Lack of sterility assurance.  There is a defect in the primary packaging of the device, which may compromise the device sterility

## Distribution

Nationwide Distribution to MD, NY, and IL

## Key facts

- **Recall number:** Z-2639-2017
- **Recalling firm:** DeRoyal Industries Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-07
- **Report date:** 2017-07-05
- **Termination date:** 2020-07-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Powell, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2639-2017

## Citation

> AI Analytics. FDA recall Z-2639-2017. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-2639-2017. Source: US FDA. Licensed CC0.

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