FDA recall Z-1736-2025

Galt Medical Corporation · Class II · device

Product

Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires

Reason for recall

Due to a potential open seal in the sterile barrier packaging.

Distribution

Worldwide - U.S. Nationwide distribution in the states of AL, FL, GA, IL, MA, OH, PA, and UT. The countries of Canada, Ireland, Israel, Korea, Qatar, and United Kingdom.

Key facts

Status: Ongoing
Initiation date: 2025-03-27
Report date: 2025-05-14
Voluntary/Mandated: Voluntary: Firm initiated
Location: Garland, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1736-2025