Device recall
Z-0541-2018: Safety-Deluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle, Catalog # 977…
FDA device recall · Class II · Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
Key facts
| Recall number (Z-number) | Z-0541-2018 |
|---|---|
| Recall event | 78950 |
| Product | Safety-Deluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle, Catalog # 977 Product Usage: Surgical procedure |
| Product code | PWY |
| Recalling firm | Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 27, 2020 |
| 510(k) numbers | K032432, K110883 |
| FEI number | 2433012 |
At a glance
- 1–9 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