Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies
FDA device recall Z-1747-2020 · posted 2020-04-27 · Terminated
Recall details
- Recalling firm
- Vascular Solutions, Inc.
- Reason for recall
- The inner lumen of the Langston catheter may separate from the hub during pressure injection.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DQO
- Quantity affected
- 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, Spa
- Date initiated
- 2020-03-16
- Date posted
- 2020-04-27
- Date terminated
- 2024-06-18
- Location
- Maple Grove, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER (K051395) | Vascular Solutions, Inc. | 2005-06-24 |