Galt Medical Corporation recalls Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires
- Recall date
- March 27, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1736-2025
- FDA classification
- Class II
- Brand / firm
- Galt Medical Corporation
- Sold / distributed
- 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.
Why it was recalled
Due to a potential open seal in the sterile barrier packaging.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires
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