Kit, Catheter, Urinary (exludes Hiv Testing)
Gastroenterology, Urology · 21 CFR 876.5130
Urinary Catheterization Kit (Excludes HIV Testing)
Recent MDR events
4 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
3 recall events for this product code
- Customed, IncTerminatedApr 14, 2016
Catalog Number: 900278
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1459-2016 · View FDA record ↗ - Customed, IncTerminatedSep 3, 2015
URETHRAL CATHETER TRAY CUSTOMED 50/CS
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-2656-2015 · View FDA record ↗ - Customed, IncTerminatedDec 16, 2014
Uretheral Catheter Tray, Catalog number 900-278.
Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
Z-0244-2015 · View FDA record ↗
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
1 clearances for this product code