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Urocare® Reusable Urinary Drainage Bottle 2,000 mL.

UROCARE PRODUCTS, INC. · Model 4100 · UDI-DI 00792293041005

KNX

510(k) clearances

2,156

Adverse events

Recalls

125

Facilities

Description

BOTTLE, URINE COLLECTION, BED SIDE, WHEELCHAIR, REUSABLE, RIGID HDPE, TUBE, HOOKS, 64 FL. OZ. (2,000 ML.) Contains/Features Include: Latex-Free, DEHP Free, 60" Drainage Tube with Nozzle Adapter and Cap #6061, Urinary Drainage Bottle Adapter #6003, Urinary Drainage Bottle Cap with Housing #4101, Anti-Reflux Valve #6001, , Graduations in 100 mL. increments, Large Opening for Easy Cleaning, Hooks for Hanging #4102, Large Finger Holes for Easy Handling and Adjustable Thumb Tube Clamp #6999.

Recalls

Date	Firm	Reason
2026-06-25	C.R. Bard Inc	Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
2026-06-25	C.R. Bard Inc	Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
2023-12-04	Cardinal Health 200, LLC	Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
2019-01-14	Teleflex Medical	The device labels are not UDI compliant. The missing UDI compliance information on the labelling would not affect the function/performance of the device itself. Other label informa
2019-01-14	Teleflex Medical	The device labels are not UDI compliant. The missing UDI compliance information on the labelling is not likely to affect the function/performance of the device itself. Other label
2017-06-02	C.R. Bard, Inc.	Customer complaint of a cut in the side of the leg bag, indicating a potential breach of the product's sterile barrier.
2016-07-11	C.R. Bard, Inc.	The product contained a latex catheter instead of a silicone catheter.
2016-06-29	C.R. Bard, Inc.	Labeling problem
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.
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.

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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.