Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies
Reported: May 6, 2020 Initiated: March 16, 2020 #Z-1747-2020
Product Description
Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies
Reason for Recall
The inner lumen of the Langston catheter may separate from the hub during pressure injection.
Details
- Recalling Firm
- Vascular Solutions, Inc.
- Units 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, Spain, Sweden, Switzerland, and United Kingdom.
- Location
- Maple Grove, MN
Frequently Asked Questions
What product was recalled? ▼
Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies. Recalled by Vascular Solutions, Inc.. Units affected: 30,877 units.
Why was this product recalled? ▼
The inner lumen of the Langston catheter may separate from the hub during pressure injection.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 6, 2020. Severity: Critical. Recall number: Z-1747-2020.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11