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Oscor, Inc. recalls AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various type
Recalled April 7, 2021 · FDA recall Z-1329-2021 · Oscor
Hazard
Potential for open seal on sterile product · FDA Class II
Units
500 devices
Sold at
US Nationwide distribution in the state of New York.
Description
Potential for open seal on sterile product
Product
AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters.
Manufacturer(s)
Oscor, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →