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.

Class I - Dangerous

🏥 Medical Devices Recalled: June 1, 2017 Master & Frank (Pinghu) Co. Surgical Instruments

What Should You Do?

Check if you have this product:
Reference No. DYNJP2229S; Lot/Serial No. 45016070513PH
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Master & Frank (Pinghu) Co., Ltd.
Reason for Recall:: 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.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

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.

Product Codes/Lot Numbers:

Reference No. DYNJP2229S; Lot/Serial No. 45016070513PH

Distribution:

Distributed in: IL

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-3079-2017