Recall Z-0110-2021 ยท DQO Catheter, Intravascular, Diagnostic
Vascular Solutions, Inc.
Langston Dual Lumen Catheter
| Date | Oct 20, 2020 (initiated Aug 31, 2020) |
| Status | Terminated |
| Reason | The inner lumen of the Langston catheter may separate from the hub during pressure injection. |
| Root cause | Process control |
| Action | The firm notified consignees that received affected product on August 26, 2020 via UPS Mail (US), email or mail (OUS). The firms immediate correction is to recall the affected devices for destruction. The notice includes instructions on subrecall for any consignees that further distributed affected product. |
| Quantity | 1,680 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, C |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051395 | LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER Vascular Solutions, Inc., Jun 24, 2005 |