Device recall
Z-1205-2007: Assorted non- sterile Tracecarts (with sterile component(s)); DeRoyal C-Section…
FDA device recall · Class II · DeRoyal Lafollette
Key facts
| Recall number (Z-number) | Z-1205-2007 |
|---|---|
| Recall event | 39374 |
| Product | Assorted non- sterile Tracecarts (with sterile component(s)); DeRoyal C-Section Tracecart, REF 53-1746.02, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal CABG Tracepak, REF 90-2838.11, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal CABG Tracecart, REF 53-1865.03, non-sterile, Rx… |
| Product code | KDD |
| Recalling firm | DeRoyal Lafollette |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 12, 2008 |
| FEI number | 3005011024 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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