Drug recall
STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended…
FDA recall event 64972 · Class II · Advanced Sterilization Products
Key facts
| Event ID | 64972 |
|---|---|
| Recall numbers | Z-1180-2013 |
| Recalling firm | Advanced Sterilization Products |
| Product type | Devices |
| Products | STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Advanced Sterilization Products is recalling certain lots of STERRAD CYCLESURE 24 Biological Indicator product because it may not have adequate data to support the entire duration of the labeled… |
| Initiation date | Apr 22, 2013 |
| Report date | May 8, 2013 |
| Termination date | Aug 1, 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: