Langston Dual Lumen Catheter — Class I medical device recall Z-0111-2021
Terminated recall by Vascular Solutions, Inc., reported 2020-10-28, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. The inner lumen of the Langston catheter may separate from the hub during pressure injection.
| Recall number | Z-0111-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vascular Solutions, Inc., Maple Grove, MN, United States |
| Recall initiated | 2020-08-31 |
| Classified | 2020-10-20 |
| Reported by FDA | 2020-10-28 |
| Terminated | 2024-06-18 |
| Distributed | 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, WY |
| Countries outside the US | AE, AT, AU, BE, BG, CA, CH, CY, CZ, DE, ES, FR, GB, GR, HK, IE, IL, IT, MX, NL, OM, PL, SA, SE, SG, SK, ZA |
| Quantity | 89,121 units |
| UPC / GTIN / UDI-DI | 10841156100513 |
| Lot numbers | 632018, 632019, 632020, 633211, 633647, 633929, 634247, 634423, 635207, 635208, 635209, 635280, 635541, 635542, 635805, 635861, 636284, 636471, 636709, 636898, 636901, 637384, 637388, 637832, 637945, 638198, 638323, 638953, 639414, 639516, 639892, 640034, 640459, 640676, 640938, 641060, 641222, 641543, 641679, 642031 and 181 more |
| Model numbers | 5540 |
Product
Langston Dual Lumen Catheter.
Reason for recall
The inner lumen of the Langston catheter may separate from the hub during pressure injection.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0111-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.