Product Wiki · Recalls · Health Canada — Medical Devices

Sage PrimaFit™ — recall 74628

Health Canada — Medical Devices · Canada · 2023-11-22 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
74628
Date of alert
2023-11-22
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Gastroenterology and urology
Product type
Medical devices
Reported risk: Cardinal Health was recently informed of a medical device recall concerning the Sage PrimaFit® external urine management for the female anatomy as a small percentage of devices in three lots (93667, 93614, 93613) may contain a tape with natural rubber latex adhesive, thus contradicting the natural rubber latex-free claim on the label. Recall start date: October 30, 2023
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/sage-primafittm

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