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0.5 Micron hydrophobic disc filter
Official notice
27 Jul 2023
Last checked
27 Jul 2023
An official Health Canada notice concerns 0.5 Micron hydrophobic disc filter. Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflecting the expiration date of the product. Specifically, an additional 3 years was added to the expiration date within the UDI barcode of the label. The identified incorrect expiration date in the UDI barcode could result in the use of impacted devices beyond the actual expiration date of the product. The clinical impact of this mislabeling is delay of therapy due to confusion of the expiration date that is listed in the barcode compared to that written on the label. Additionally, the potential for the use of a product longer than indicated with the potential for degraded functionality was identified in the circumstance that the user scans the barcode for expiration tracking and/or explicitly confirms the expiration of the product with the UDI barcode. Recall Start Date: July 13, 2023 Published 2023-07-27.
What to do now
Contact the manufacturer if you require additional information.
Recall number
74001
Official notice
2023-07-27
The hazard
The hazard
Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflecting the expiration date of the product. Specifically, an additional 3 years was added to the expiration date within the UDI barcode of the label. The identified incorrect expiration date in the UDI barcode could result in the use of impacted devices beyond the actual expiration date of the product. The clinical impact of this mislabeling is delay of therapy due to confusion of the expiration date that is listed in the barcode compared to that written on the label. Additionally, the potential for the use of a product longer than indicated with the potential for degraded functionality was identified in the circumstance that the user scans the barcode for expiration tracking and/or explicitly confirms the expiration of the product with the UDI barcode. Recall Start Date: July 13, 2023
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
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Company & contacts
Company & contacts
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Brand: Smiths Medical Asd, 0.5 Micron Hydrophobic Disc Filter.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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