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Surity Male External Catheter
Wellspect AB · Model 38021 · UDI-DI 07333387056623
1
510(k) clearances
4,134
Adverse events (12 deaths)
1
Recalls
48
Facilities
Description
Non-invasive, single-use device for management of urinary incontinence in adults with male anatomy
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-10-23 | Sage Products Inc | 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 |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.