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Urocare® Leg Bag Holder, Upper Large
UROCARE PRODUCTS, INC. · Model 6384 · UDI-DI 00792293063847
10
510(k) clearances
402
Adverse events
7
Recalls
121
Facilities
Description
HOLDER, LEG BAG, LATEX-FREE, VELCRO, REUSABLE, UPPER LARGE A simple and cost effective solution to a prevent contact between the leg bag and the skin. Reducing sweating while allowing the skin to breathe freely. Their unique construction provides a simple method for securing a urine collection bag to the leg without the use of leg straps which are often the cause of circulation restriction in some individuals.
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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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.