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Urocare® Tubing White-Rubber with Connector & Sterile 0.31" x 18"

UROCARE PRODUCTS, INC. · Model 6017 · UDI-DI 00792293060174

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510(k) clearances

2,118

Adverse events

Recalls

125

Facilities

Description

TUBING, URINE COLLECTION, OSTOMY, WHITE-RUBBER, CONNECTOR, REUSABLE, STERILE Features “Reverse-Grip” technology and graduated barbs to provide a secure hold on most standard sized drainage or extension tubing. May be used to connect Uro-Con® or Uro-Cath® male external catheters, Foley® indwelling catheters and reusable or disposable urinary drainage bags, bottles or other urinary and ostomy appliances. Provides a snug fit on most standard sized drainage ports/outlets while resisting kinks. DEHP-Free, Latex-Free and Sterile (EO). Includes #6010 Large Tubing Connector preassembled.

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.