Master & Frank (Pinghu) Co., Ltd. recalls MEDLINE SIRUS Surgical Gown, Strong Protection, Poly-Reinforced, Breathable Film Sleeve, XXL-XLONG Sterile Single-Use G…
- Recall date
- June 1, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-3079-2017
- FDA classification
- Class II
- Brand / firm
- Master & Frank (Pinghu) Co., Ltd.
- Sold / distributed
- Domestic: IL.
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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