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Bag, Urine Collection, Leg, For External Use, Sterile
FDA product code FAQ · Class 1 · Gastroenterology, Urology
203
Registered devices
399
Adverse events
7
Recalls
18
510(k) clearances
Devices with this code
Urocare® Leg Bag Holder, Lower Large — UROCARE PRODUCTS, INC.Medegen Medical Products, LLC — MEDEGEN MEDICAL PRODUCTS, LLCSimPro™ Set — Wellspect ABSimPro™ Set — Wellspect ABUro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.) — UROCARE PRODUCTS, INC.MediChoice — OWENS & MINOR DISTRIBUTION, INC.Vive — VIVE HEALTH LLCUrocare® Fabric Leg Strap Kit with Velcro® Fasteners, Small (Set of 2) — UROCARE PRODUCTS, INC.RUSCH — TELEFLEX INCORPORATEDMcKesson — MCKESSON MEDICAL-SURGICAL INC.Uro-Safe® Disposable Vinyl Leg Bag 32 oz. (1,000 mL.) — UROCARE PRODUCTS, INC.Medline — MEDLINE INDUSTRIES, INC.GentleCath Hydrophilic Kit — Wellspect ABLeg Bag — C. R. Bard, Inc.McKesson — MCKESSON MEDICAL-SURGICAL INC.Urocare® Thumb Tube Clamp, Adjustable — UROCARE PRODUCTS, INC.Urocare® Tubing Clear-Vinyl with Nozzle Adapter, Cap & Sterile 0.28" ID x 18" — UROCARE PRODUCTS, INC.McKesson — MCKESSON MEDICAL-SURGICAL INC.CARDINAL HEALTH — Cardinal Health 200, LLCFlexicare — FLEXICARE MEDICAL LIMITEDUrocare® Tubing White-Rubber with Connector 0.31" ID x 18" — UROCARE PRODUCTS, INC.GentleCath Hydrophilic Kit — Wellspect ABUrocare® Tubing Connector, Large 0.38" OD x 2.25" — UROCARE PRODUCTS, INC.Leg Bag — C. R. Bard, 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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