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EXP Pharmaceutical Services Corp recalls Medical Device Exchange 12MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 9-AVP2-012;
Recalled August 5, 2015 · FDA recall Z-2234-2015 · EXP Pharmaceutical Services
Hazard
EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems. · FDA Class II
Units
1
Sold at
Distributed in DC and the states of CO, CA, FL, TX, and AR.
Description
EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.
Product
Medical Device Exchange 12MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 9-AVP2-012; EXP (repackager), Aga Medical (OEM) Transcatheter septal occluder
Manufacturer(s)
EXP Pharmaceutical Services Corp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →