Sirus Surgical Gown

Starting date:

June 7, 2017

Posting date:

July 6, 2017

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-63834

• Reason
• Affected products

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.

Affected products