FDAClass IISeptember 6, 2017

MEDLINE SIRUS Surgical Gown recall

MEDLINE SIRUS Surgical Gown, Strong Protection, Poly-Reinforced, Breathable Film Sleeve, XXL-XLONG Sterile Single-Use Gown; Sold in kit with Sterile…

Why was MEDLINE SIRUS Surgical Gown 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
MEDLINE SIRUS Surgical Gown, Strong Protection, Poly-Reinforced, Breathable Film Sleeve, XXL-XLONG Sterile Single-Use Gown; Sold in kit with Sterile…
Recalling firm
Master & Frank (Pinghu) Co., Ltd.
Quantity
2,160 units
Distribution
Domestic: IL.
Recall date
September 6, 2017
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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