STERRAD 200 Sterilization System, P/N 10201 Product Usage: The STERRAD 200 Sterilization System is a general purpose, lo
FDA device recall Z-1027-2013 · posted 2013-03-30 · Terminated
Recall details
- Recalling firm
- Advanced Sterilization Products
- Reason for recall
- The recall was initiated because Advanced Sterilization Products (ASP) has determined that the STERRAD 100NX and STERRAD 200 Sterilization Systems may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions.
- Action taken
- Advanced Sterilization Products sent an Urgent Medical Device Field Safety Notification letter dated March 22, 2013 to all customers. The letter identified the affected products, problem and actions to be taken. Customers are instructed to report any complaints or suspected problems with their STERRAD 100NX and/or STERRAD 200 System to ASP Professional Services directly at (888) 783-7723 and select option #2.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MLR
- Quantity affected
- 1038 units
- Distribution
- US Nationwide Distribution
- Date initiated
- 2013-03-22
- Date posted
- 2013-03-30
- Date terminated
- 2013-09-30
- Location
- Irvine, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STERRAD 200 STERILIZER (K030429) | Advanced Sterilization Products | 2003-08-18 |