Events

Recall of SIRUS SURGICAL GOWN

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MEDLINE CANADA CORPORATION.

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
    144477
  • Event Risk Class
    II
  • Event Initiated Date
    2017-06-07
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Medline industries was informed by the vendor that one lot of sirus surgical gown product code dynjp2229s was manufactured with inconsistent sealing of the breathable sleeve seam material. the gown is manufactured using a spunbond-meltblown-spunbond (sms} base material which is used for the body of the gown. the chest area/critical zone is reinforced with a polyethylene coated spunbond polypropylene material. the arms are manufactured using a breathable film material which is stitched to the body. the gown is labeled as an aami level 4 gown. 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 defect was detected during laboratory testing per astm f 1671 - standard test method for resistance of materials used in protective clothing to penetration by blood-borne pathogens using phi-x174 bacteriophage penetration where failures were seen at the sleeve seam. no complaints or mdr's have been filed for open seams or for fluid passing through the seams onto the user.

Device

SIRUS SURGICAL GOWN
  • Model / Serial
    Model Catalog: DYNJP2229S (Lot serial: 45016070513PH)
  • Product Description
    SIRUS SURGICAL GOWN
  • Manufacturer
    MEDLINE CANADA CORPORATION

Manufacturer

MEDLINE CANADA CORPORATION