Drug recall
STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a…
FDA recall event 64692 · Class II · Advanced Sterilization Products
Key facts
| Event ID | 64692 |
|---|---|
| Recall numbers | Z-1026-2013, Z-1027-2013 |
| Recalling firm | Advanced Sterilization Products |
| Product type | Devices |
| Products | STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate…, STERRAD 200 Sterilization System, P/N 10201 Product Usage: The STERRAD 200 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 200 process to inactivate… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Mar 22, 2013 |
| Report date | Apr 10, 2013 |
| Termination date | Sep 30, 2013 |
| 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: