Drug recall
0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI: 114135150/(01)20886333008074…
FDA recall event 85398 · Class I · Argon Medical Devices, Inc
Key facts
| Event ID | 85398 |
|---|---|
| Recall numbers | Z-1791-2020, Z-1792-2020 |
| Recalling firm | Argon Medical Devices, Inc |
| Product type | Devices |
| Products | 0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI: 114135150/(01)20886333008074. RxOnly.STERILE EO, 0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly STERILE EO |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The stiffness of the soft end of the guidewire caused tissue perforation. |
| Initiation date | Dec 4, 2019 |
| Report date | May 13, 2020 |
| Termination date | Apr 1, 2024 |
| City | Athens |
| State | TX |
| Country | United States |
| FEI number | 1625425 |
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: