Sage PrimaFit™
Brand(s)
Last updated
Summary
Product
Sage PrimaFit™
Issue
Medical devices - Performance issue
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Sage PrimaFit™ |
93613 |
SAGE5400 |
Issue
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology & Urology
Companies
Sage Products, LLC
3909 Three Oaks Rd, Cary, Illinois, United States, 60013
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74628
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