FDA-Device2015-08-05Class II
Medical Device Exchange Chocolate Balloon Catheter/Over-the-Wire; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number CF14-150-25040-OTW. EXP (repackager), TriReme Medical (OEM) Catheter, angioplasty, peripheral, transluminal
EXP Pharmaceutical Services Corp
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.
Sold states
Distributed in DC and the states of CO, CA, FL, TX, and AR.
Affected count
1
Manufactured in
48021Warm Springs Boulevard, N/A, Fremont, CA, United States
Products
Medical Device Exchange Chocolate Balloon Catheter/Over-the-Wire; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number CF14-150-25040-OTW. EXP (repackager), TriReme Medical (OEM) Catheter, angioplasty, peripheral, transluminal
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2251-2015Don't want to check this manually?
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