Recall Z-0741-2012 ยท MLR Sterilizer, Chemical
Advanced Sterilization Products
STERRAD 200 Sterilizer, Hydrogen Peroxide Gas Plasma Sterilizer, Chemical Sterilizer. STERRAD 200; Product Usage: The STERRAD Sterilization System is a low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
| Date | Jan 13, 2012 (initiated Jan 23, 2012) |
| Status | Terminated |
| Reason | ASP determined that an internal filter in the vacuum pump on the STERRAD 200 System is subject to wear over time. |
| Root cause | Nonconforming Material/Component |
| Action | ASP will send an Urgent Medical Device Correction letter to all affected customers on January 23rd, 2012. The letter describes the product, problem and the actions to be taken. The letter informs customers that ASP has determined that the vacuum pump in the STERRAD 200 System may cause the emission of a slightly increased level of hydrogen peroxide (H2O2) vapor into the surrounding environment if not regularly serviced or replaced. The letter instructed customers to read the "Issue Description" and "Recommendations" sections in the letter, pass on the notice with any staff that work with or a |
| Quantity | 395 units |
| Distribution | Worldwide Distribution - USA (nationwide) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030429 | STERRAD 200 STERILIZER Advanced Sterilization Products, Aug 18, 2003 |