Device recall
Z-2443-2015: Covidien Argyle Infant Heel Warmers (no tab) Item Code: MH00002N Product Usage…
FDA device recall · Class II · Covidien LLC
Key facts
| Recall number (Z-number) | Z-2443-2015 |
|---|---|
| Recall event | 71784 |
| Product | Covidien Argyle Infant Heel Warmers (no tab) Item Code: MH00002N Product Usage: Intended for application of the right amount of heat to an infants heel for blood sampling |
| Product code | MPO |
| Recalling firm | Covidien LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 31, 2017 |
| 510(k) numbers | K964523 |
| FEI number | 1219930 |
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