Drug recall
Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam Product Usage: The SKYTRON Integrity…
FDA recall event 82650 · Class II · Skytron, Div. The KMW Group, Inc
Key facts
| Event ID | 82650 |
|---|---|
| Recall numbers | Z-1779-2019 |
| Recalling firm | Skytron, Div. The KMW Group, Inc |
| Product type | Devices |
| Products | Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam Product Usage: The SKYTRON Integrity 270 Steam Sterilizer for use in health care facilities. The Integrity Sterilizer… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Weld attaching the air heater assembly to the main sterilizer unit has shown signs of fatigue/failure |
| Initiation date | Apr 18, 2019 |
| Report date | Jun 19, 2019 |
| Termination date | Apr 17, 2020 |
| City | Grand Rapids |
| State | MI |
| Country | United States |
| FEI number | 1825014 |
At a glance
- 1–9 Products in this recall
- 1–9 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: