Recall Z-1570-2009 ยท MLR Sterilizer, Chemical
Advanced Sterilization Products
Sterrad 50 Sterilizer, Product Code 10050. Low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
| Date | Jun 30, 2009 (initiated Jan 12, 2009) |
| Status | Terminated |
| Reason | The capacitor in the vacuum pump component within the Sterrad 50 System could overheat and potentially create a hazardous condition inside the system, resulting in smoke and/or fire. |
| Root cause | Other |
| Action | Advanced Sterilization Products (ASP) sent an "Urgent: Product Correction" letter dated January 12, 2009 to each consignee informing them of the issue and instructed them to report smoke or a burning odors in or around their STERRAD 50 System. ASP strongly recommended for consignees to follow their facility's safety protocols and if possible, immediately disconnect the STERRAD 50 System from its electrical source. Customers were instructed to contact ASP to schedule an onsite visit to investigate the issue. If the issue is caused by a malfunctioning capacitor in the vacuum pump, the firm w |
| Quantity | 1,151 units. |
| Distribution | Worldwide Distribution -- US, Germany, Italy, France, United Kingdom, Switzerland, Benelex, Uruguay, Venezuela, Argentina, Chile, Columbia, Belgium, Puerto Rico, Mexico, Philipines, Australia, Japan, Korea, Malaysia, Taiwan, Middle East, Peru, Canada, Czech Republic, Portugal, Spain, Sweden, Hungary |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981625 | STERRAD 50 STERILIZER Advanced Sterilization Products, Jan 11, 1999 |