Device recall
Z-2113-2020: Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Jude…
FDA device recall · Class II · Stryker Sustainability Solutions
Key facts
| Recall number (Z-number) | Z-2113-2020 |
|---|---|
| Recall event | 85413 |
| Product | Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Jude Medical, Size 9F (3.2mm), Length 90 cm, Sterile EO, Rx Only, Quantity 1, UDI: 07613327376067 |
| Product code | OWQ |
| Recalling firm | Stryker Sustainability Solutions |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 14, 2022 |
| 510(k) numbers | K182238 |
| FEI number | 3009350690 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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