Class I — Vascular Solutions, Inc.
| Recalling firm | Vascular Solutions LLC |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | The inner lumen of the Langston catheter may separate from the hub during pressure injection. |
| Product | Langston Dual Lumen Catheter. |
| Quantity | 1,745 units |
| Distribution | Domestic Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL ,GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ,NM ,NV ,NY ,OH ,OK,OR, PA ,PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY. International Distribution: Austria, Australia, Belgium, Bulgaria, Canada, Cyprus, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Mexico, … |
| Initiated | 2020-08-31 |
| Classified | 2020-10-20 |
| Terminated | 2024-06-18 |
| Recall number | Z-0112-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Vascular Solutions, Inc. (Z-0112-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86433/
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