Home › AMSINO INTERNATIONAL, INC. › AMSure® Urethral Self Catheterization Kit 16Fr.

AMSure® Urethral Self Catheterization Kit 16Fr.

AMSINO INTERNATIONAL, INC. · Model 1 · UDI-DI 10704411007593

FCM Prescription

510(k) clearances

804

Adverse events (2 deaths)

Recalls

Facilities

Description

AMSure® Urethral Self Catheterization Kit 16Fr. with • Pre-lubricated • Closed System CONTENTS STERILIZED USING ETHYLENE OXIDE: 1 each Pre-lubricated PVC Urethral Catheter, 16” (40 cm) Length 1 each 1100 mL Collection Bag with Insertion Tip 1 each Waterproof Underpad, 13”x18” (340 x 450 mm) 1 pair Cuffed Vinyl Gloves 1 each Waste Disposal Bag 1 each Gauze Pad, 4”x4”(100 x 100 mm) NON-STERILE CONTENTS: 1 pack BZK Swabsticks (3) 1 pack Benzalkonium Chloride Prep Pad

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.