Health product recall

Sage PrimaFit™

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 93614 93667 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