Home / Recalls / Sage Products Inc / Z-0356-2024

Z-0356-2024 Class II Ongoing

Recalled by Sage Products Inc — Cary, IL

Recall Details

Product Type
Devices
Report Date
November 29, 2023
Initiation Date
October 23, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
174,960 devices

Product Description

stryker Sage PrimaFit External Urine Management System for the Female Anatomy

Reason for Recall

A 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

Distribution Pattern

US and Canada

Code Information

GTIN 00618029600417, Lot Codes: 93667, 93614, 93613

Other recalls by Sage Products Inc

  • Z-2139-2019 Class II — Toothete Oral Care Sodium Bicarbonate Mouthpaste, Net Wt. 1/3 oz/ 9g, included i (December 5, 2018)
  • D-0354-2018 Class II — QCare RX Q2 Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconat (August 22, 2017)
  • D-0383-2018 Class II — Toothette Oral Care Suction Toothbrushes with Perox-A-Mint solution. Contains 1 (August 22, 2017)
  • D-0365-2018 Class II — Toothette Oral Care Single Use System with Perox-A-Mint solution and Mouth Mois (August 22, 2017)
  • D-0364-2018 Class II — Toothette Oral Care Single Use System With Perox-A-Mint solution. Contains: 2 To (August 22, 2017)
  • D-0371-2018 Class II — Q Care Continue Care for the non-ventilated patient. Contains, 1 Covered Yankaue (August 22, 2017)
  • D-0407-2018 Class II — Q Care RX Petite Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Glu (August 22, 2017)
  • D-0398-2018 Class II — Q.Care Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CH (August 22, 2017)
  • D-0403-2018 Class II — Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chl (August 22, 2017)
  • D-0405-2018 Class II — Q.Care Oral Cleansing & Suctioning System Suction Toothbrush Compatible with Chl (August 22, 2017)