Recall Z-2335-2012
Steris Corporation · initiated August 1, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Model #: P6500, S/N 400000 through 406294
Reason for recall
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
STERIS sent a Urgent Voluntary Field Correction Notice letter dated August 1, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. STERIS has received no reports of injuries associated with the disconnection of a SYSTEM IE water hose. STERIS Corporation will instill new hoses and connections on your SYSTEM IE Liquid Chemical Sterilant Processing System. For further information or if you have any questions regarding our visit to your facility, please contact STERIS Field Service Dispatch at 1-800-333-8828.
Details
- Recall number
- Z-2335-2012
- Initiated
- August 1, 2012
- Posted by FDA
- September 7, 2012
- Terminated
- June 6, 2014
- Product code
- MED – Sterilant, Medical Devices
- Quantity
- 6,051 units
- Distribution
- Worldwide Distribution -- USA (nationwide) and the countries of Bahrain and Hong Kong.
- Recalling firm
- Steris Corporation, Mentor, OH