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Uro-Kit® Reusable Latex Leg Bag System 10 oz.
UROCARE PRODUCTS, INC. · Model 99510 · UDI-DI 00792293995100
10
510(k) clearances
2,156
Adverse events
21
Recalls
125
Facilities
Description
BAG, URINE COLLECTION, LEG, KIT, REUSABLE, LATEX, ODOR BARRIER, STRAPS, SPORT-RIGHT SMALL 10 FL. OZ. (300 ML.) Contains: 1 Reusable Latex Urinary Leg Bag #9510, 1 Fabric Sport Bag Strap #6342, 1 Bottle of Urolux Appliance Cleanser #700204, 1 Small Parts Cleansing Brush #7003, 1 Adaptor with Thumb Clamp #6005, 1 Tubing 18" Long with Connector #6016, 14 Male External Catheters #5122535 and Illustrated Use and Care Instructions.
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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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.