Product Wiki · Recalls · Health Canada — Medical Devices

MICROSTIC PLUS — recall 44397

Health Canada — Medical Devices · Canada · 2016-09-08 · Type III

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Agency: Health Canada — Medical Devices
Recall identifier: 44397
Date of alert: 2016-09-08
Country / jurisdiction: Canada
Risk level: Type III
Risk type: recall
Product category: Medical devices
Product type: Medical devices
Notice status: Archived by the issuing authority — kept for reference

Reported risk: An issue was identified with the stiffer coaxial micro-introducer 4FR and 5FR after a field complaint reported that the rotating luer detached from the dilator hub during use. The function of the rotating luer is to fasten the dilator to the shield during insertion. Affected lots have an outer diameter of the dilator hub that is slightly smaller than is capable of securing the dilator to the sheath.

Primary source: https://recalls-rappels.canada.ca/en/alert-recall/microstic-plus

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MICROSTIC PLUS — recall 44397

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