Drug recall
STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be used as a standard method for…
FDA recall event 66981 · Class II · Advanced Sterilization Products
Key facts
| Event ID | 66981 |
|---|---|
| Recall numbers | Z-0604-2014 |
| Recalling firm | Advanced Sterilization Products |
| Product type | Devices |
| Products | STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Advanced Sterilization Products (ASP) is recalling the STERRAD Cyclesure Biological Indicator (BI) because ASP has identified a microscopic intermittent and low frequency flaw in the outer vial of the… |
| Initiation date | Nov 26, 2013 |
| Report date | Jan 8, 2014 |
| Termination date | Mar 5, 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: