FDA Device recall Z-0112-2021
Langston Dual Lumen Catheter
- FDA Device
- Class I
- terminated
- Published 2020-10-28
On 2020-10-28 the FDA classified a Class I recall of Langston Dual Lumen Catheter by Vascular Solutions, citing the inner lumen of the Langston catheter may separate from the hub during pressure injection.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0112-2021 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2020-08-31 |
| Published | 2020-10-28 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Vascular Solutions |
| 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, WY |
Product
Langston Dual Lumen Catheter.
Reason
The inner lumen of the Langston catheter may separate from the hub during pressure injection.
Identifiers
| code_info | Model Number: 5545, UDI 10841156100520 total 1745, Lots: 634357, 645111, 649740, 650126, 655647, 657411, 661790, 666866…Model Number: 5545, UDI 10841156100520 total 1745, Lots: 634357, 645111, 649740, 650126, 655647, 657411, 661790, 666866, 673313, 638819, 650127, 659802, 672219, 675001, 638547, 668503. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0112-2021%22
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