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Z-0112-2021 Class I Terminated

Recalled by Vascular Solutions, Inc. — Maple Grove, MN

FDA device recall Z-0112-2021 was initiated by Vascular Solutions, Inc. on August 31, 2020 and is designated Class I. Reason for recall: The inner lumen of the Langston catheter may separate from the hub during pressure injection. The recall status is terminated (terminated June 18, 2024). Affected quantity: 1,745 units.

Recall Details

Product Type: Devices
Report Date: October 28, 2020
Initiation Date: August 31, 2020
Termination Date: June 18, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,745 units

Product Description

Langston Dual Lumen Catheter.

Reason for Recall

The inner lumen of the Langston catheter may separate from the hub during pressure injection.

Distribution Pattern

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.

Code Information

Model Number: 5545, UDI 10841156100520 total 1745, Lots: 634357, 645111, 649740, 650126, 655647, 657411, 661790, 666866, 673313, 638819, 650127, 659802, 672219, 675001, 638547, 668503.