LANGSTON recallZ-0112-2021 · Vascular Solutions, Inc. · initiated Aug 31, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Vascular Solutions, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The inner lumen of the Langston catheter may separate from the hub during pressure injection.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-0112-2021
- Status
- Terminated
- Initiated by the company
- Aug 31, 2020
- Posted by the FDA
- Oct 20, 2020
- Recalling firm
- Vascular Solutions, Inc.
- Quantity
- 1,745 units
- Product code
- DQO
- FDA submissions
- K051395
- 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 description
Langston Dual Lumen Catheter.
Code information (models, lots, serial numbers)
Model Number: 5545, UDI 10841156100520 total 1745, Lots: 634357, 645111, 649740, 650126, 655647, 657411, 661790, 666866, 673313, 638819, 650127, 659802, 672219, 675001, 638547, 668503.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- LANGSTON IPN913560Teleflex Incorporated · CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 86433).
- Z-0110-2021 · TerminatedLangston Dual Lumen Catheter
- Z-0111-2021 · TerminatedLangston Dual Lumen Catheter.
- Z-0113-2021 · TerminatedLangston Dual Lumen Catheter.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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