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Bag, Urine Collection, Leg, For External Use, Sterile
FDA product code FAQ · Class 1 · Gastroenterology, Urology
208
Registered devices
410
Adverse events
7
Recalls
18
510(k) clearances
Devices with this code
Urocare® Tubing Clear-Vinyl with Nozzle Adapter & Cap 0.28" ID x 8.5" — UROCARE PRODUCTS, INC.GentleCath Hydrophilic Kit — Wellspect ABUrocare® Fabric Leg Strap with Velcro® Fasteners, Sport sml/MED 15" to 24" DIA — UROCARE PRODUCTS, INC.Medline — MEDLINE INDUSTRIES, INC.GentleCath Hydrophilic Kit — Wellspect ABSimPro™ Set — Wellspect ABU-Bag Urine Collector — ASPEN SURGICAL PRODUCTS, INC.U-Bag Urine Collector — ASPEN SURGICAL PRODUCTS, INC.Neil Medical Group — Neil Medical GroupFlexicare — FLEXICARE MEDICAL LIMITEDFlexicare — FLEXICARE MEDICAL LIMITEDExact Medical Manufacturing, Inc. — EXACT MEDICAL MANUFACTURING, INC.Conveen Security+ — Coloplast A/SHalsted Health — Flex Source International, Inc.CARDINAL HEALTH — Cardinal Health 200, LLCGentleCath Hydrophilic Kit — Wellspect ABGentleCath Hydrophilic Kit — Wellspect ABUrocare® Tubing Clear-Vinyl with Connector 0.31" x 18" — UROCARE PRODUCTS, INC.TruCath — HR PHARMACEUTICALS INC.AMSure® Urinary Leg Bag — AMSINO INTERNATIONAL, INC.GentleCath Hydrophilic Kit — Wellspect ABUrocare® Tubing Clear-Vinyl with Nozzle Adapter, Cap & Sterile 0.28" ID x 18" — UROCARE PRODUCTS, INC.Dover — Cardinal Health, Inc.McKesson — MCKESSON MEDICAL-SURGICAL INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-10-19 | MEDLINE INDUSTRIES, LP - Northfield | Undeclared latex |
| 2023-10-19 | MEDLINE INDUSTRIES, LP - Northfield | Undeclared latex |
| 2023-10-19 | MEDLINE INDUSTRIES, LP - Northfield | Undeclared latex |
| 2011-06-02 | Teleflex Medical | Sterile integrity cannot be guaranteed. |
| 2011-06-02 | Teleflex Medical | Sterile integrity cannot be guaranteed. |
| 2003-04-30 | Medegen Medical Products, LLC | Finished products were not sterilized. |
| 2003-03-25 | C.R. Bard, Inc., Urological Division | There is a potential for package seals to be open after sterilization. |
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