Drug recall
STERRAD 100NX, Product Code: 10104 The STERRAD Steri lization System is a low temperature general purpose…
FDA recall event 66815 · Class II · Advanced Sterilization Products
Key facts
| Event ID | 66815 |
|---|---|
| Recall numbers | Z-0402-2014, Z-0403-2014 |
| Recalling firm | Advanced Sterilization Products |
| Product type | Devices |
| Products | STERRAD 100NX, Product Code: 10104 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices., STERRAD NX, Product Code: 10033 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Advanced Sterilization Products (ASP) is recalling the STERRAD NX and STERRAD 100NX sterilization systems because ASP has determined that the bronchoscopes may contain a polyurethane material in the… |
| Initiation date | Nov 11, 2013 |
| Report date | Dec 4, 2013 |
| Termination date | Jan 22, 2014 |
| City | Irvine |
| State | CA |
| Country | United States |
| FEI number | 3003662624 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: