STERRAD Sterilizers ( Models 100S, 50, 200) Compatible Medical Device Reference List for US Customers, Document Numbers
FDA device recall Z-0844-2008 · posted 2008-02-07 · Terminated
Recall details
- Recalling firm
- Advanced Sterilization Products
- Reason for recall
- Outdated Compatibility Lists: Recalling firm has decided to discontinue dissemination of Compatible Medical Device Reference Lists and instrument assessment activities
- Action taken
- Notification letters, Urgent Product Correction, were sent to customers beginning on November 13, 2007 via UPS overnight. Customers were notified this action was being taken as a result of an investigation by the firm determined that all brand- and model-specific compatibility lists and associated instrument assessments provided to STERRAD Sterilization System customers are now out-of-date. User were instructed to discontinue their use and destroy them.
- Root cause
- Other
- Status
- Terminated
- Product code
- MLR
- Quantity affected
- 9,686 units
- Distribution
- Worldwide: USA, France, Germany, Italy, The UK, Switzerland, Benelux,Uruguay,Venezuela,Argentina,Chile,Colombia,Ecuador,Belgium, Puerto Rico, Hong Kong,Indonesia,Mexico,Philippines,Australia,Austria,C
- Date initiated
- 2007-11-12
- Date posted
- 2008-02-07
- Date terminated
- 2011-12-19
- Location
- Irvine, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STERRAD NX STERILIZER (K042116) | Advanced Sterilization Products | 2005-04-22 |
| STERRAD 200 STERILIZER (K030429) | Advanced Sterilization Products | 2003-08-18 |
| STERRAD 100S STERILIZER (K991999) | Advanced Sterilization Products | 2000-06-15 |
| STERRAD 50 STERILIZER (K981625) | Advanced Sterilization Products | 1999-01-11 |