Recall Z-0844-2008 ยท MLR Sterilizer, Chemical
Advanced Sterilization Products
STERRAD Sterilizers ( Models 100S, 50, 200) Compatible Medical Device Reference List for US Customers, Document Numbers 15-53229 & 15-53230; STERRAD NX Sterilizers Compatible Medical Device Reference List for NX Customers, Product Code 15-53231; STERRAD NX System Brochure, Product Code AD-53421-001, Advanced Sterilization Products, Irvine, CA
| Date | Feb 7, 2008 (initiated Nov 12, 2007) |
| Status | Terminated |
| Reason | Outdated Compatibility Lists: Recalling firm has decided to discontinue dissemination of Compatible Medical Device Reference Lists and instrument assessment activities |
| Root cause | Other |
| Action | 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compatibility lists and associated instrument assessments provided to STERRAD Sterilization System customers are now out-of-date.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. |
| Quantity | 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,China, Greece,Ireland,Israel, Japan,Korea,Malaysia,Singapore,Taiwan,Thailand, Turkey, Middle East, Pe |
| FDA record | Open on fda.gov |