Device recall
Z-1601-2018: HYPOTHERMIA MITTS Supportive in Cancer, packaged under the following brands: (a)…
FDA device recall · Class II · Southwest Technologies Inc
Key facts
| Recall number (Z-number) | Z-1601-2018 |
|---|---|
| Recall event | 78877 |
| Product | HYPOTHERMIA MITTS Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), TM7006 (b) Elasto-Gel(TM), TM7006LV (c) Elasto-Gel(TM), TM7007 (d) Elasto-Gel(TM), TM7008 (e) Elasto-Gel(TM), TM7008b (f) Elasto-Gel(TM), TM7009 (g) Elasto-Gel(TM), TM7010 (h) Elasto-Gel(TM), TM7011 (i)… |
| Recalling firm | Southwest Technologies Inc |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 1929833 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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