FDA-Device2025-05-14Class II
Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires
Galt Medical Corporation
Hazard
Due to a potential open seal in the sterile barrier packaging.
Sold states
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.
Affected count
200 needles
Manufactured in
2220 Merritt Dr, N/A, Garland, TX, United States
Products
Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1736-2025Don't want to check this manually?
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