FDA recall Z-1747-2020

Product

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

Reason for recall

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

Distribution

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.

Key facts

Status

Terminated

Initiation date

2020-03-16

Report date

2020-05-06

Termination date

2024-06-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Maple Grove, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1747-2020