Product Safety Recalls

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Sage Products Inc Recall 93229

Description: stryker Sage PrimaFit External Urine Management System for the Female Anatomy

Sage Products Inc Recall 93229 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0356-2024
Event ID93229
Event Descriptionstryker Sage PrimaFit External Urine Management System for the Female Anatomy
Product TypeDevices
DistributionUS and Canada
Quantity174,960 devices
Recall ReasonA small percentage of devices in three lots of product may contain a tape with a natural rubber latex adhesive which is not declared on the label
Device Classification20231129
Device Code InfoGTIN 00618029600417, Lot Codes: 93667, 93614, 93613
Center Classification Date20231120
Recall Initiation Date20231023
Recalling FirmSage Products Inc
Initial Notification Letter
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