Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies
This recall has been terminated (originally issued April 27, 2020).
- Company
- Vascular Solutions, Inc.
- Recall Initiated
- March 16, 2020
- Posted
- April 27, 2020
- Terminated
- June 18, 2024
- Recall Number
- Z-1747-2020
- Quantity
- 30,877 units
- Firm Location
- Maple Grove, MN
- Official Source
- View on FDA website ↗
Reason for Recall
The inner lumen of the Langston catheter may separate from the hub during pressure injection.
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.
Lot / Code Info
Model 5540; UDI 10841156100513; Lots 651278, 651457, 651920, 652097, 652176, 652459, 652628, 652777, 653053, 653319, 653443, 653565, 653776, 653863, 654010, 654190, 654340, 654514, 654657, 654889, 654890, 655128, 655287, 655460, 655465, 655738, 655869, 656191, 656533, 656554, 656727, 656801, 657030, 657243, 657517, 657627, 657680, 657866, 658018, 658151, 658250, 658438, 658541, 658671, 658824, 658984, 659122, 659217, 659362, 659443, 659630, 659855, 660075, 660199, 660288, 660397, 660590, 660717, 660823, 660910, 661139, 661257, 661474, 662824
Root Cause
Process control
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.