Z-0113-2021Class I

Langston Dual Lumen Catheter

Name: Z-0113-2021 Langston Dual Lumen Catheter
Creator: Vascular Solutions, Inc.
Published: 2020-08-31
License: https://open.fda.gov/license/

Vascular Solutions LLC / initiated 2020-08-31 / Terminated / root cause: manufacturing process

FDA source

Vascular Solutions, Inc. began a recall of Langston Dual Lumen Catheter on 2020-08-31. FDA classified it as Class I and gives the reason as "The inner lumen of the Langston catheter may separate from the hub during pressure injection". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0113-2021
Classification: Class I
Status: Terminated
Initiated: 2020-08-31
Posted: 2020-10-20
Terminated: 2024-06-18
Recalling firm: Vascular Solutions LLC
Product: Langston Dual Lumen Catheter.
Product code: DQO Catheter, Intravascular, Diagnostic
Reason for recall: The inner lumen of the Langston catheter may separate from the hub during pressure injection.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Model Number: 5550, UDI 10841156100537 total 2990, Lots: 637973, 640204, 659555, 660597, 633668, 663767, 669593, 659856, 644096, 676528, 672481, 632704, 656792, 658273, 666755, 635885.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0113-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0110-2021	Class I	Terminated	Voluntary: Firm initiated	2020-10-28	2020-10-20
Z-0111-2021	Class I	Terminated	Voluntary: Firm initiated	2020-10-28	2020-10-20
Z-0112-2021	Class I	Terminated	Voluntary: Firm initiated	2020-10-28	2020-10-20
Z-0113-2021	Class I	Terminated	Voluntary: Firm initiated	2020-10-28	2020-10-20

Product code DQO

K061565Class IILangston Dual Lumen CatheterVascular Solutions, Inc. / cleared 2006-08-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)