EXP Pharmaceutical Services Corp recalls Medical Device Exchange 12MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 9-AVP2-012; EXP…

Recall date

February 11, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2234-2015

FDA classification

Class II

Brand / firm

EXP Pharmaceutical Services Corp

Sold / distributed

Distributed in DC and the states of CO, CA, FL, TX, and AR.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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