Home › AMSINO INTERNATIONAL, INC. › AMSure® Urethral Self Catheterization Kit

AMSure® Urethral Self Catheterization Kit

AMSINO INTERNATIONAL, INC. · Model 1 · UDI-DI 10704411003571

FCM Prescription

510(k) clearances

800

Adverse events (2 deaths)

Recalls

Facilities

Description

AMSure® Urethral Self Catheterization Kit with RPOLISHED® Eyes, Pre-lubricated, Closed System CONTENTS: 1 Pre-lubricated PVC Urethral Catheter, 16" (40cm) Length, 1 1100ml Collection Bag with Insertion Tip, 3 Povidone-Iodine Swabsticks, 1 Benzalkonium Chloride Prep Pad, 2 Cuffed Vinyl Gloves, 1 Warerproof Underpad, 13" × 18" (340 × 450 mm), 1 Waste Disposal Bag, 1 Gauze Pad, 4" × 4" (100 × 100 mm)

Recalls

Date	Firm	Reason
2024-04-08	MEDLINE INDUSTRIES, LP - Northfield	Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma
2023-12-04	Cardinal Health 200, LLC	Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
2023-05-15	MEDLINE INDUSTRIES, LP - Northfield	Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
2022-11-01	Cardinal Health	Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropria
2022-11-01	Cardinal Health	Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropria
2022-11-01	Cardinal Health	Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropria
2022-11-01	Cardinal Health	Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropria
2022-11-01	Cardinal Health	Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropria
2022-11-01	Cardinal Health	Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropria
2022-05-25	Mckesson Medical-Surgical Inc. Corporate Office	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

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.