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U.S. Department of Health and Human Services

Class 1 Device Recall Langston Dual Lumen Catheter

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  Class 1 Device Recall Langston Dual Lumen Catheter see related information
Date Initiated by Firm August 31, 2020
Create Date October 20, 2020
Recall Status1 Open3, Classified
Recall Number Z-0113-2021
Recall Event ID 86433
510(K)Number K061565  
Product Classification Catheter, intravascular, diagnostic - Product Code DQO
Product Langston Dual Lumen Catheter.
Code Information Model Number: 5550, UDI 10841156100537 total 2990, Lots: 637973, 640204, 659555, 660597, 633668, 663767, 669593, 659856, 644096, 676528, 672481, 632704, 656792, 658273, 666755, 635885.        
Recalling Firm/
Manufacturer		 Vascular Solutions, Inc.
6420 Sycamore Ln N
Maple Grove MN 55369-6013
For Additional Information Contact Paul Campbell
763-656-4300
Manufacturer Reason
for Recall		 The inner lumen of the Langston catheter may separate from the hub during pressure injection.
FDA Determined
Cause 2		 Process control
Action 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.
Quantity in Commerce 2990 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DQO and Original Applicant = VASCULAR SOLUTIONS, INC.
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