Events

Recall of Device Recall MEDLINE SIRUS Surgical Gown, Strong Protection Surgical Gown, Surgeon

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Master & Frank (Pinghu) Co., Ltd..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77633
  • Event Risk Class
    Class 2
  • Event Number
    Z-3079-2017
  • Event Initiated Date
    2017-06-01
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156974
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Gown, surgical - Product Code FYA
  • Reason
    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.
  • Action
    Master & Frank Enterprise Co., LTD is working directly with Medline Industries, Inc., on this recall. A written notification was emailed to Medline Industries, Inc. on June 1, 2017 notifying them of the recall and further instructions. Consignee was instructed to quarantine and destroy any recalled product and to respond to the recall communication. The attached recall response form requested that the consignee notify all of their own customers of the recall.

Device

Device Recall MEDLINE SIRUS Surgical Gown, Strong Protection Surgical Gown, Surgeon
  • Model / Serial
    Reference No. DYNJP2229S; Lot/Serial No. 45016070513PH
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Domestic: IL.
  • Product 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.
  • Manufacturer
    Master & Frank (Pinghu) Co., Ltd.

Manufacturer

Master & Frank (Pinghu) Co., Ltd.
  • Manufacturer Address
    Master & Frank (Pinghu) Co., Ltd., 2 No. 2000 Xingping Road, Hangzhou China
  • Manufacturer Parent Company (2017)
    Master & Frank (Pinghu) Co. Ltd.
  • Source
    USFDA