Device recall
Z-1995-2013: Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO…
FDA device recall · Class II · Blue Belt Technologies MN
Key facts
| Recall number (Z-number) | Z-1995-2013 |
|---|---|
| Recall event | 65834 |
| Product | Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO. Product Usage: The intended use of this device is t protect equipment from contamination during a variety of procedures throughout the clinical setting. |
| Product code | KKX |
| Recalling firm | Blue Belt Technologies MN |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 14, 2013 |
| 510(k) numbers | K050322 |
| FEI number | 3010266064 |
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