FDA recall Z-1968-2023

Product

Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16

Reason for recall

Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer connection portion of the dilator hub that cracks or dislodges during use, which renders the dilator component unusable, and can require the use of a replacement device.

Distribution

Worldwide - US Nationwide distribution in the states of PA, UT, FL, PA, OH, GA, MA, NV, CA, NY, NJ and the countries of UK, AU, TR, FR, CH, NO.

Key facts

Status

Ongoing

Initiation date

2023-05-08

Report date

2023-06-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Garland, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1968-2023