Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies

FDA Recall Z-1747-2020 · Posted 2020-04-27

Recalling FirmVascular Solutions, Inc.
Recall StatusTerminated
Product CodeDQO
Date Initiated2020-03-16
Date Terminated2024-06-18
Product Quantity30,877 units

Reason for Recall

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

Firm Action

The firm notified consignees that received affected product on March 26, 2020 via UPS Mail (US), email or mail (OUS). The firm s immediate correction is to recall the affected devices for destruction. The notice includes instructions on subrecall for any consignees that further distributed affected product.

Root Cause

Process control

Distribution Pattern

Worldwide distribution. US nationwide, Austria, Australia, Belgium, Canada, Czech Republic, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Slovakia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051395LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETERVascular Solutions, Inc. · 2005-06-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑