FDAFDA · Food and drugs·Recall number Z-3079-2017
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.
Published September 6, 2017 · Recall initiated: June 1, 2017
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Master & Frank (Pinghu) Co., Ltd.
- Distributor
- Domestic: IL.
- Lot
- Reference No. DYNJP2229S; Lot/Serial No. 45016070513PH
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- China
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