Drug recall
Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW.
FDA recall event 89998 · Class II · Getinge Usa Sales Inc
Key facts
| Event ID | 89998 |
|---|---|
| Recall numbers | Z-1078-2022 |
| Recalling firm | Getinge Usa Sales Inc |
| Product type | Devices |
| Products | Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Inadequate documentation verifying whether device installation has been executed in accordance with the manufacturer's requirements. This can lead to installation failure modes and hazardous… |
| Initiation date | Apr 1, 2022 |
| Report date | May 25, 2022 |
| City | Wayne |
| State | NJ |
| Country | United States |
| FEI number | 3013876692 |
At a glance
- 1–9 Products in this recall
- None 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: