FDA-Device2015-08-05Class II
Medical Device Exchange - KII FIOS FIRST ENTRY 5X100MM; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number CFF03 EXP (repackager), Applied Medical (OEM) Laparoscope, General & Plastic Surgery.
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
7
Manufactured in
48021Warm Springs Boulevard, N/A, Fremont, CA, United States
Products
Medical Device Exchange - KII FIOS FIRST ENTRY 5X100MM; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number CFF03 EXP (repackager), Applied Medical (OEM) Laparoscope, General & Plastic Surgery.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2213-2015Don't want to check this manually?
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