Drug recall
Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Jude Medical, Size 9F (3.2mm)…
FDA recall event 85413 · Class II · Stryker Sustainability Solutions
Key facts
| Event ID | 85413 |
|---|---|
| Recall numbers | Z-2113-2020 |
| Recalling firm | Stryker Sustainability Solutions |
| Product type | Devices |
| Products | 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 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A subset of temporary intracardiac ultrasound catheters are labeled with the incorrect expiration date. They are mislabeled as having a shelf life of two years, while the actual shelf life is one… |
| Initiation date | Mar 27, 2020 |
| Report date | Feb 3, 2021 |
| Termination date | Oct 14, 2022 |
| City | Tempe |
| State | AZ |
| Country | United States |
| FEI number | 3009350690 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: