September 6, 2017Medical DevicesFDA
Master & Frank (Pinghu) Co., Ltd. recalls MEDLINE SIRUS Surgical Gown, Strong Protection, Poly-Reinforced, Breathable Film Sleeve, XXL-XLONG Sterile Single-Use Go
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.