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FDAFebruary 11, 2015device

Medical Device Exchange Aerosizer Stent Sizing Device; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 90129-501. EXP (repackager), Merit Medical (OEM) Prosthesis, tracheal, expandable

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

exp pharmaceutical servicesexpexp pharmaceutical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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