Recall Z-1747-2020 ยท DQO Catheter, Intravascular, Diagnostic
Vascular Solutions, Inc.
Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies
| Date | Apr 27, 2020 (initiated Mar 16, 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 March 26, 2020 via UPS Mail (US), email or mail (OUS). The firm s 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 | 30,877 units |
| Distribution | Worldwide distribution. US nationwide, Austria, Australia, Belgium, Canada, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Slovakia, South Africa, Spain, Sweden, Switzerland, and United Kingdom. |
| 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 |