Reported Sep 6, 2017 · Ongoing
MEDLINE SIRUS Surgical Gown, Strong Protection, Poly-Reinforced, Breathable Film Sleeve, XXL-XLONG Sterile Single-Use…
Master & Frank (Pinghu) Co., Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Master & Frank (Pinghu) Co., Ltd. · 2 No. 2000 Xingping Road · Hangzhou, N/A · N/A
Is this the product you have?
- 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.
- Lot codes and dates
Reference No. DYNJP2229SLot/Serial No. 45016070513PH
- Amount recalled
- 2,160 units
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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