Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.)
UROCARE PRODUCTS, INC. · Model 78180 · UDI-DI 00792293781802
Description
BAG, URINE COLLECTION, LEG, DISPOSABLE, VINYL, STRAPS, TWIST TYPE DRAIN VALVE, MEDIUM, 18 FL. OZ. (550 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 defects through each phase of manufacturing and packaged individually in an easy-open Zip-Loc® bag with two(2) “latex-free” leg straps and application instructions. 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 |
|---|---|---|
| 2023-12-04 | 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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