Home › Device types › NWO
Kit, Catheter, Urinary (Exludes Hiv Testing)
FDA product code NWO · Class 2 · Gastroenterology, Urology
34
Registered devices
4
Adverse events
3
Recalls
1
510(k) clearances
Devices with this code
SimPro™ Set — Wellspect ABSimPro™ Set — Wellspect ABGentleCath Hydrophilic Kit — Wellspect ABGentleCath Hydrophilic Kit — Wellspect ABSimPro™ Set — Wellspect ABGentleCath Hydrophilic Kit — Wellspect ABSimPro™ Set — Wellspect ABGentleCath Hydrophilic Kit — Wellspect ABGentleCath Hydrophilic Kit — Wellspect ABSimPro™ Set — Wellspect ABSimPro™ Set — Wellspect ABGentleCath Hydrophilic Kit — Wellspect ABCARDINAL HEALTH — Cardinal Health 200, LLCGentleCath Hydrophilic Kit — Wellspect ABGentleCath Hydrophilic Kit — Wellspect ABCARDINAL HEALTH — Cardinal Health 200, LLCSimPro™ Set — Wellspect ABSimPro™ Set — Wellspect ABGentleCath Hydrophilic Kit — Wellspect ABSimPro™ Set — Wellspect ABSimPro™ Set — Wellspect ABGentleCath Hydrophilic Kit — Wellspect ABGentleCath Hydrophilic Kit — Wellspect ABGentleCath Hydrophilic Kit — Wellspect AB
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-01-07 | Customed, Inc | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. |
| 2015-07-10 | Customed, Inc | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. |
| 2014-10-08 | Customed, Inc | Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.