Device recall
Z-0769-05: Medline Custom Open Heart CDS Kit (non-sterile), reorder number CDS840144A…
FDA device recall · Class II · Medline Industries, Inc.
Key facts
| Recall number (Z-number) | Z-0769-05 |
|---|---|
| Recall event | 31528 |
| Product | Medline Custom Open Heart CDS Kit (non-sterile), reorder number CDS840144A, which contains Meridian Nexus Unilimb Rebreathing Circuit, part 40301-1-30, among other components needed for open heart surgery; Made in USA by Medline Industries, Inc., Mundelein, IL 60060 |
| Product code | LRO |
| Recalling firm | Medline Industries, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 17, 2005 |
| FEI number | 3000717925 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1,000+ 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