Convex Two-Piece Skin Barrier Recall [Australia]


Australia FlagAustralia/Canberra: Logo - ConvaTec Australia Pty LtdConvaTec Australia Pty Ltd, a Victoria, New South Wales establishment, recalls certain batch/lots of various Convex Two-Piece Skin Barriers due to suspected device centering failure and consequential risk of laceration damage, all serious health and safety hazards.

ACCC: http://ht.ly/3d5930pxXZT

Direct link: https://www.productsafety.gov.au/recall/convatec-australia-pty-ltd-various-convex-two-piece-skin-barriers

Additional information:
The Australian Competition & Consumer Commission (“ACCC”) reports the following Medical Products are subject to this recall:

  • Various Convex Two-Piece Skin Barriers sold under the Natura, Surfit and Combihesive Wafers brands, manufactured between February 2017 to September 2018, with an ARTG designation of 235593 (Convatec Australia Pty Ltd – Ostomy base plate, convex).

A complete list of recalled products is available as a PDF list here: https://www.productsafety.gov.au/system/files/Affected%20Product%20Name%2C%20Product%20Code%20%26%20Lot%20Number%20list.pdf

According to the ACCC, the starter hole (i.e., stoma hole) on the Convex Two-Piece Skin Barriers may be off-centre. If this defect occurs, it can cause cuts to the skin, resulting in injury to the user.

If you believe you have purchased or have in your possession the recalled Convex Two-Piece Skin Barriers, please do not use them. Instead, kindly return the product to the store, outlet or distributor where you purchased it for a full refund.

==> If you have a medical emergency, please contact 0-0-0, your closest hospital or emergency centre equipped to properly treat lacerations.

==> To see other recalls and notifications caused by suspected faulty and/or dangerous Skin Barriers, please search for “skin” or more generically, “medical equipment” using the Search Box at the top of this page.

If you have any questions about this recall notification, please contact ConvaTec Help Desk on 1800 339 412 during normal business hours, Australian Eastern Standard Time, Monday to Friday.

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More information about this recall:
ACCC PRA number: 2019/17816
Recalls Direct RIN: 12054-2019
Want to read more about this recall?
==> Please click on the links above to visit the originating site.
Want to read more about other recalls?
==> Please click on the links below.

General information:
More recalls? Back to the main Recalls Direct page:
==> http://www.RecallsDirect.com/
About the Recalls Direct service:
==> http://wp.me/P2bVty-2
Visit the Living Safely site:
==> http://www.LivingSafely.org/
Report an unsafe product you purchased in Australia [external: new window opens]:
==> https://www.productsafety.gov.au/contact-us/for-consumers/report-an-unsafe-product
Search for a recalled product on the ACCC Web site [external: new window opens]:
==> http://www.productsafety.gov.au/recalls/browse-all-recalls

We welcome your feedback:
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E. & O. E.

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