The SYSTEM 1E Liquid Sterilant Processing System. The SYSTEM 1E Liquid Sterilant Processing System is intended for the l
FDA device recall Z-2335-2012 · posted 2012-09-07 · Terminated
Recall details
- Recalling firm
- Steris Corporation
- 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.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MED
- Quantity affected
- 6,051 units
- Distribution
- Worldwide Distribution -- USA (nationwide) and the countries of Bahrain and Hong Kong.
- Date initiated
- 2012-08-01
- Date posted
- 2012-09-07
- Date terminated
- 2014-06-06
- Location
- Mentor, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM (K102462) | STERIS Corporation | 2010-09-21 |
| SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEM (K101409) | STERIS Corporation | 2010-08-02 |
| SYSTEM 1.5 STERILE PROCESSING SYSTEM (K090036) | STERIS Corporation | 2010-04-05 |