Drug recall
ECATS E 850 Bariatric Bed, True Air Technologies, Inc.
FDA recall event 67924 · Class II · SCM True Air Technologies LLC
Key facts
| Event ID | 67924 |
|---|---|
| Recall numbers | Z-1630-2014, Z-1631-2014, Z-1632-2014 |
| Recalling firm | SCM True Air Technologies LLC |
| Product type | Devices |
| Products | ECATS E 850 Bariatric Bed, True Air Technologies, Inc., JK Bariatric Beds, True Air Technologies, Inc., MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors. |
| Initiation date | Mar 18, 2014 |
| Report date | May 28, 2014 |
| Termination date | Jun 11, 2018 |
| City | Louisville |
| State | KY |
| Country | United States |
| FEI number | 3001452084 |
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: