FDAFDA · Food and drugs·Recall number Z-2335-2012
The SYSTEM 1E Liquid Sterilant Processing System. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.
Published September 19, 2012 · Recall initiated: August 1, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The firm initiated a recall after complaint investigations revealed that when the units are left on and not in use at night and/or on weekends the hose disconnects/separates resulting in water leakage that can cause damage to property.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Steris Corporation
- Distributor
- Worldwide Distribution -- USA (nationwide) and the countries of Bahrain and Hong Kong.
- Lot
- Model #: P6500, S/N 400000 through 406294
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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