Device recall
Z-1061-2007: Gebauer''s Pain Ease Medium Stream -Topical Anesthetic Skin Refrigerant is a…
FDA device recall · Class II · Gebauer Company
Key facts
| Recall number (Z-number) | Z-1061-2007 |
|---|---|
| Recall event | 37778 |
| Product | Gebauer''s Pain Ease Medium Stream -Topical Anesthetic Skin Refrigerant is a vapocoolant (skin refrigerant) packed in an aerosol container. Rx only. 103.5ml (3.5 fl. oz.) can-(Product Number-0386-0008-03) |
| Product code | MLY |
| Recalling firm | Gebauer Company |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 30, 2009 |
| 510(k) numbers | K032671 |
| FEI number | 1519179 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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