Omnigon Hydroframe Medical Device Recall [Australia]


Australia FlagAustralia/Canberra: Logo - OmnigonOmnigon Pty Ltd, a Burnley, Victoria establishment, recalls certain batch/lots of Hydroframe Stoma Medical Devices from the Australian marketplace due to undeclared Manuka Honey, a known allergen, source of sensitisation and possible trigger of Anaphylaxis, a serious and potential fatal situation, requiring immediate medical intervention.

ACCC: http://ht.ly/eRSD30rfCR7

Direct link: https://www.productsafety.gov.au/recall/omnigon-pty-ltd-hydroframe-with-manuka-honey

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

  • Hydroframe Stoma Medical Devices, sold with a part number designation of (X)MHWAFH33, an ARTG number of 131228 and batch/lots of KL522, KL523, KL524, KL535, KL536, KL537, KL576, KL582, KM662, KM663, KM669, KM670, KM715, KN632, KN633, KN637, KN638, KN639 and KN691

=> No barcodes, APNs, EANs, UPCs, NDCs, DINs, item numbers, best-before date codes, manufacturing date codes, production dates, expiry dates, regulatory approval designations, registration numbers, agency approval designations or other identification numbers were listed with this recall notification.

According to the ACCC, certain batch/lot of the Hydroframe Stoma Medical Devices were released without a statement on the label identifying that the product contains Manuka Honey. Users of there products may be exposed to ingredients they are sensitive or allergic to and could suffer an adverse reaction. Users will not be able to check the label to identify the possible cause and seek appropriate treatment.

If you believe you have purchased or have in your possession the recalled Medical Devices, please do not use them. Instead, kindly return the product to the store 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 Anaphylaxis.

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

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Australian Department of Health Coronavirus Tips___________________________________________________________

If you have any further questions, comments or complaints about this recall notification, please contact Omnigon Customer Service on 1800 819 274 during normal business hours, Australian Standard Time, Monday to Friday.

==> To see other recalls and notifications caused by undeclared Manuka Honey, please search for “honey” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold by Omnigon, please search for “Omnigon” using the Search Box at the top of this page.

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More information about this recall:
ACCC PRA number: 2020/18605
Recalls Direct RIN: 13646-2020
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

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E. & O. E.

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