# FDA recall Z-2531-2017

> **Creganna Medical Devices** · Class II · device recall initiated 2017-05-22.

## Product

Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004EPTMCA85400

## Reason for recall

Lack of sterility assurance.

## Distribution

Distributed in MA.

## Key facts

- **Recall number:** Z-2531-2017
- **Recalling firm:** Creganna Medical Devices
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-05-22
- **Report date:** 2017-06-21
- **Termination date:** 2018-05-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Galway, N/A, Ireland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2531-2017

## Citation

> AI Analytics. FDA recall Z-2531-2017. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2531-2017. Source: US FDA. Licensed CC0.

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