Paragon branded Oxygenator Recall [Canada]


Canada FlagCanada/Ottawa: Logo - Health CanadaChalice Medical Limited, a Worksop, Nottinghamshire, UK establishment, recalls certain Paragon branded Oxygenators due to suspected wrong expiry dates and consequential risk of operational impairment and possible injury, all serious health and safety hazards.

HCSC: http://ht.ly/2uYH30kFB7j

Direct link: http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2018/67094r-eng.php

Additional information:
Health Canada/Santé Canada (“HCSC”) reports the following Oxygenators are subject to this recall:

  • Paragon branded Oxygenators, sold with batch/lots numbers 012550, 012551 or 012552

Please consult the photograph above for details of the product’s design and retail presentation.

==> No barcodes, UPCs, item numbers or other identification numbers were listed with this recall notification.

According to Health Canada, the company has determined that incorrect expiry dates may have been allocated to one of the components used during the manufacture of the recalled Oxygenators. This resulted in the products being given two (2) or three (3) months extra shelf life on top of the validated two (2) year operational life.

If you believe you have purchased or have in your possession any of the recalled Paragon branded Oxygenators, please do not rely on their stated expiry date. Instead, kindly contact your supplier or distributor for accurate expiry dates for your equipment. Do not stop using your Oxygenator.

Please note: the Canada Consumer Product Safety Act prohibits recalled products from being redistributed, sold or even given away in Canada.

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

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

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More information about this recall:
HCSC ID number: RA-67094
Recalls Direct RIN: 10332-2018
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 Canada [external: new window opens]:
==> http://www.hc-sc.gc.ca/cps-spc/advisories-avis/incident/index-eng.php
Search for a recalled product on the Health Canada Web site [external: new window opens]:
==> http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php

We welcome your feedback:
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E. & O. E.

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