Device recall
Z-1235-2020: Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple…
FDA device recall · Class II · Cardinal Health 200, LLC
Key facts
| Recall number (Z-number) | Z-1235-2020 |
|---|---|
| Recall event | 84834 |
| Product | Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included. |
| Product code | LRO |
| Recalling firm | Cardinal Health 200, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 19, 2023 |
| FEI number | 3001236905 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1,000+ 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