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Urocare® Disposable Urinary Drainage Bag 64 oz. (2,000 mL.)

UROCARE PRODUCTS, INC. · Model 4200 · UDI-DI 00792293042002

KNX FAQ

510(k) clearances

2,118

Adverse events

Recalls

125

Facilities

Description

BAG, URINE COLLECTION, BED SIDE, WHEELCHAIR, DISPOSABLE, VINYL, T-TYPE DRAIN VALVE, 64 FL. OZ. (2,000 ML.) Contains/Features Include: Latex-Free, Needleless, Sterile (EO), 50" Drainage Tube, Reinforced, Universal, Hanger Strap, Anti-Reflux Chamber, Needleless Sample Port, Clear Front with White Back for easy monitoring for blood or other substances in urine, Graduated Nozzle Adapter with Cap, Graduations in 100 mL. and 25 mL., Breather Patch, Bed Sheet Clip and T-Type Drain Valve.

Recalls

Date	Firm	Reason
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 is not likely to affect the function/performance of the device itself. Other label
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
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.
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.