Langston Dual Lumen Catheter.
Reported: October 28, 2020 Initiated: August 31, 2020 #Z-0111-2021
Product Description
Langston Dual Lumen Catheter.
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
- 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, UT, VA, VT, WA, WI, WV and WY. International Distribution: Austria, Australia, Belgium, Bulgaria, Canada, Cyprus, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Oman, Poland, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates and United Kingdom.
- Location
- Maple Grove, MN
Frequently Asked Questions
What product was recalled? ▼
Langston Dual Lumen Catheter.. Recalled by Vascular Solutions, Inc.. Units affected: 89,121 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 October 28, 2020. Severity: Critical. Recall number: Z-0111-2021.
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