# FDA recall Z-3079-2017

> **Master & Frank (Pinghu) Co., Ltd.** · Class II · device recall initiated 2017-06-01.

## Product

MEDLINE SIRUS Surgical Gown, Strong Protection, Poly-Reinforced, Breathable Film Sleeve, XXL-XLONG Sterile Single-Use Gown; Sold in kit with Sterile Gown/Hand Towel/CSR Wrap and boxes of 18 Gowns.

## Reason for recall

The sleeve seam of the breathable material was found to have inconsistent sealing, which has the potential to allow fluid to flow pass through the protective seam.

## Distribution

Domestic: IL.

## Key facts

- **Recall number:** Z-3079-2017
- **Recalling firm:** Master & Frank (Pinghu) Co., Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2017-06-01
- **Report date:** 2017-09-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hangzhou, N/A, China

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3079-2017

## Citation

> AI Analytics. FDA recall Z-3079-2017. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-3079-2017. Source: US FDA. Licensed CC0.

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