Drug recall
Vascular Solutions Twin-Pass.023" Dual Access Catheter, model 5230. Sterilized with Ethylene Oxide. The…
FDA recall event 75243 · Class I · Vascular Solutions, Inc.
Key facts
| Event ID | 75243 |
|---|---|
| Recall numbers | Z-0053-2017, Z-0054-2017, Z-0055-2017 |
| Recalling firm | Vascular Solutions, Inc. |
| Product type | Devices |
| Products | Vascular Solutions Twin-Pass .023" Dual Access Catheter, model 5230. Sterilized with Ethylene Oxide. The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the coronary and/or…, Vascular Solutions Twin-Pass Dual Access Catheter, models 5200, 5210, and 5230. Sterilized with Ethylene Oxide. The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the…, Vascular Solutions Twin-Pass RX Dual Access Catheter, model 5210. Sterilized with Ethylene Oxide. The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the coronary and/or… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Vascular Solutions is recalling Twin-Pass dual access catheters because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the… |
| Initiation date | Sep 16, 2016 |
| Report date | Oct 26, 2016 |
| Termination date | May 4, 2018 |
| City | Maple Grove |
| State | MN |
| Country | United States |
| FEI number | 3002827704 |
At a glance
- 1–9 Products in this recall
- 10–99 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: