Langston Dual Lumen Catheter.
FDA device recall Z-0111-2021 · posted 2020-10-20 · 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 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DQO
- Quantity affected
- 89,121 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,
- Date initiated
- 2020-08-31
- Date posted
- 2020-10-20
- Date terminated
- 2024-06-18
- Location
- Maple Grove, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER (K051395) | Vascular Solutions, Inc. | 2005-06-24 |