# FDA recall Z-0582-2020

> **Bard Peripheral Vascular Inc** · Class II · device recall initiated 2019-02-14.

## Product

PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter

## Reason for recall

Complaints received that products packaged with the incorrect introducer sheath size.

## Distribution

US - Nationwide    OUS - None

## Key facts

- **Recall number:** Z-0582-2020
- **Recalling firm:** Bard Peripheral Vascular Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-02-14
- **Report date:** 2019-12-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tempe, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0582-2020

## Citation

> AI Analytics. FDA recall Z-0582-2020. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0582-2020. Source: US FDA. Licensed CC0.

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