Device recall
Z-0456-2012: ThermoSuit Manufactured for Life Recovery Systems. HD, LLC, 170 Kinnelon Rd…
FDA device recall · Class II · Life Recovery Systems HD, LLC
Key facts
| Recall number (Z-number) | Z-0456-2012 |
|---|---|
| Recall event | 60636 |
| Product | ThermoSuit Manufactured for Life Recovery Systems. HD, LLC, 170 Kinnelon Rd. Kinnelon, NJ 07405 USA Tel.: (973) 283-2800 FAx.: (973) 283-2910 Temperature reduction in patients where clinically indicated; Monitoring of patient temperature |
| Product code | NZE |
| Recalling firm | Life Recovery Systems HD, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 24, 2013 |
| 510(k) numbers | K061023 |
| FEI number | 3006059109 |
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