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Galt Medical Corporation recalls Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16
Recalled June 21, 2023 · FDA recall Z-1968-2023 · Galt Medical
Hazard
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. · FDA Class II
Units
490
Sold at
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.
Description
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.
Product
Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16
Manufacturer(s)
Galt Medical Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →