CLASS II ONGOING Device recall · Reported 29 Nov 2023 · FDA Enforcement Report
stryker Sage PrimaFit External Urine Management System recalled
Sage Products is recalling stryker Sage PrimaFit External Urine Management System for the Female Anatomy. The recall was initiated on 23 Oct 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0356-2024
- FDA event ID
- 93229
- Recalling firm
- Sage Products, Cary, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Oct 2023
- FDA classified
- 20 Nov 2023
- Reported
- 29 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 23 Oct 2023 | Recall initiated by company | |
| 20 Nov 2023 | Classified by FDA | +28 days |
| 29 Nov 2023 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
stryker Sage PrimaFit External Urine Management System for the Female Anatomy
Where it was distributed
US and Canada
Questions about this recall
Why was it recalled?
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
Which lots are affected?
GTIN 00618029600417, Lot Codes: 93667, 93614, 93613
Where was it sold?
US and Canada
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Sage Products
All 72| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | 2% Chlorhexidine Gluconate* Cloth, Non-sterile recalled by Sage ProductsChlorhexidine Gluconate | Sage Products | Other | Nationwide |
| Device | CLASS II | Toothete Oral Care Sodium Bicarbonate Mouthpaste recalled | Sage Products | Other | Nationwide |
| Drug | CLASS II | Q CARE q4 Oral Cleaning & Suctioning System Contains recalled | Sage Products | Packaging Defects | Nationwide |
| Drug | CLASS II | Q CARE q2 Oral Cleansing & Suctioning System recalled by Sage Products | Sage Products | Packaging Defects | Nationwide |
| Drug | CLASS II | Toothette Oral Care Suction Toothbrushes with Perox-A-Mint solution recalled | Sage Products | Other | Nationwide |
Other Other Medical Devices recalls
All 13,857| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: Major Pack recalled by Medline Industries | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Peds Sinus Pack recalled by Medline Industries | Medline Industries | Other | Nationwide |
| Device | CLASS II | SmartPath to dStream for XR and 3.0T recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Achieva 1.5T, Achieva 1.5T Conversion recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Mfc Craniotomy Pack recalled | Medline Industries | Other | Nationwide |