Device recall
Z-0797-2013: Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in…
FDA device recall · Class II · Custom Healthcare Systems, Inc.
Key facts
| Recall number (Z-number) | Z-0797-2013 |
|---|---|
| Recall event | 64084 |
| Product | Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy. |
| Product code | FCH |
| Recalling firm | Custom Healthcare Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 8, 2013 |
| FEI number | 1121091 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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