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AMSure® Preconnected Urethral Tray
AMSINO INTERNATIONAL, INC. · Model 1 · UDI-DI 10704411017776
FCM
Prescription
10
510(k) clearances
800
Adverse events (2 deaths)
43
Recalls
58
Facilities
Description
– 1200ml Drainage Bag with Pre-Connected 14 Fr Vinyl Urethral Catheter(China) – CSR Wrap(China)– Waterproof Absorbent Underpad(China) – Pre-Cuffed Nitrile Gloves (2)(China) – Fenestrated Drape(China) – Povidone-Iodine Swabsticks (3)(China) – Package Sterile Lubricating Jelly(USA) – 2oz Specimen Container with ID Label(China)
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 |
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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.