Device recall
Z-0016-2012: DeRoyal (R) Heat/Moist Exchange, REF 83-000042, Rx Only, NON-STERILE…
FDA device recall · Class II · Deroyal Industries, Inc. Lafollette
Key facts
| Recall number (Z-number) | Z-0016-2012 |
|---|---|
| Recall event | 59854 |
| Product | DeRoyal (R) Heat/Moist Exchange, REF 83-000042, Rx Only, NON-STERILE, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA: Intended Use: Varies by kit; an anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia… |
| Product code | OFD |
| Recalling firm | Deroyal Industries, Inc. Lafollette |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 30, 2013 |
| FEI number | 3005011024 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database