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Uro-Safe® Disposable Vinyl Leg Bag 32 oz. (1,000 mL.)

UROCARE PRODUCTS, INC. · Model 76320 · UDI-DI 00792293763204

FAQ KNX

510(k) clearances

402

Adverse events

Recalls

121

Facilities

Description

BAG, URINE COLLECTION, LEG, DISPOSABLE, VINYL, STRAPS, TWIST TYPE DRAIN VALVE, LARGE, 32 FL. OZ. (1,000 ML.) Uro-Safe® bags have the first ever, built-in, anti-reflux valve that is virtually self-cleaning and interference free... ensuring uninterrupted flow and problem free use. Because our anti-reflux valve is enclosed in a hard valve housing, it can't be held shut even when in sitting or reclining positions like other inferior products. Why settle for anything else? Uro-Safe® vinyl leg bags are for use with Foley® indwelling or male external catheters and urostomy drainage. Each Uro-Safe® bag is hand-tested for defect through each phase of manufacturing and packaged individually in a sterile, easy, peel-open pouch with two(2) “latex-free” leg straps. Features/Contains: Latex-Free, DEHP-Free, Anti-Reflux Valve Chamber, Clear Vinyl on Both Sides, "Latex-Free" Leg Straps with Buttons #60062 and Illustrated Application Instructions.

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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Data 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.