Device recall
Z-2095-2021: Infant Heel Warmer without Attachment Tab, Nonsterile, Active Product SKU…
FDA device recall · Class II · Cardinal Health 200, LLC
Key facts
| Recall number (Z-number) | Z-2095-2021 |
|---|---|
| Recall event | 88173 |
| Product | Infant Heel Warmer without Attachment Tab, Nonsterile, Active Product SKU MH00002N The infant heel warmer is activated at the point of care by squeezing the pouch. This mixes the substrates inside the pouch causing an exothermic chemical reaction, warming the pouch, which is then applied to the heel… |
| Product code | MPO |
| Recalling firm | Cardinal Health 200, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 1, 2023 |
| 510(k) numbers | K964523 |
| FEI number | 3014524790 |
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