AMSure® Foley Catheter Tray
AMSINO INTERNATIONAL, INC. · Model 1 · UDI-DI 10704411019596
Description
"•100% Silicone Foley Catheter (sterilized using ethylene oxide) (China) •FlexGRIP for Foley 11-18 Fr (sterilized using irradiation) (Poland) •Wrap, Drape, Fenestrated Drape (sterilized using ethylene oxide) (China) •Catheter Lubricating Jelly Sachet 5g (sterilized using irradiation) (USA) •Nitrile Gloves (2)(sterilized using ethylene oxide) (China) •Forceps (sterilized using ethylene oxide) (China) •benzalkonium Chloride Prep Pad (non-sterile) (USA) •10 mL Pre-filled Syringe with Sterile Water (sterilized using irradiation) (China) •Specimen Container, Lid and Label (sterilized using ethylene oxide) (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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