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Medtronic nonabsorbable sutures
Official notice
13 Dec 2022
Last checked
13 Dec 2022
An official Health Canada notice concerns Medtronic nonabsorbable sutures. Medtronic has determined that there were manufacturing errors in the packaging of the listed nonabsorbable sutures that may cause a gap or wrinkle in the breather pouch seal resulting in a sterile barrier breach. The potential harms of a sterile barrier breach include infection or vision loss for ophthalmic procedures in cases where there is direct patient contact. Through 01-November-2022, Medtronic has received no complaints of packaging integrity defects or reports of serious patient injury related to this issue. There are no additional patient management recommendations for patients where potentially affected non-absorbable sutures in the scope of this recall were used during a procedure. These patients should continue to be monitored in accordance with the registered medical facility's standard care protocols with consideration to the specific use. Recall start date: December 1, 2022 Published 2022-12-13.
What to do now
Contact the manufacturer if you require additional information.
Recall number
72355
Official notice
2022-12-13
The hazard
The hazard
Medtronic has determined that there were manufacturing errors in the packaging of the listed nonabsorbable sutures that may cause a gap or wrinkle in the breather pouch seal resulting in a sterile barrier breach. The potential harms of a sterile barrier breach include infection or vision loss for ophthalmic procedures in cases where there is direct patient contact. Through 01-November-2022, Medtronic has received no complaints of packaging integrity defects or reports of serious patient injury related to this issue. There are no additional patient management recommendations for patients where potentially affected non-absorbable sutures in the scope of this recall were used during a procedure. These patients should continue to be monitored in accordance with the registered medical facility's standard care protocols with consideration to the specific use. Recall start date: December 1, 2022
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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Risk / hazard
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.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Covidien, Medtronic Nonabsorbable Sutures.
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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