FDA-Device2017-09-06Class II
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.
Master & Frank (Pinghu) Co., Ltd.
Hazard
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.
Sold states
Domestic: IL.
Affected count
2,160 units
Manufactured in
2 No. 2000 Xingping Road, N/A, Hangzhou, N/A, China
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3079-2017Don't want to check this manually?
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