Device recall
Z-2483-2018: Presource PBDS, Kit, No Spiro Diabetes. Kit includes a exerciser volumetric 5000…
FDA device recall · Class II · Cardinal Health 200, LLC
Key facts
| Recall number (Z-number) | Z-2483-2018 |
|---|---|
| Recall event | 80289 |
| Product | Presource PBDS, Kit, No Spiro Diabetes. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage: The kit is provided to a patient pre-surgery, as part of the Enhanced… |
| Product code | LRP |
| Recalling firm | Cardinal Health 200, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 4, 2019 |
| FEI number | 3001236905 |
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