FDA-Device2015-08-05Class II
Medical Device Exchange Surgical Gown - Flyte Hood Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 408-800 EXP (repackager) Stryker (OEM) Person protection during 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
10
Manufactured in
48021Warm Springs Boulevard, N/A, Fremont, CA, United States
Products
Medical Device Exchange Surgical Gown - Flyte Hood Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 408-800 EXP (repackager) Stryker (OEM) Person protection during surgery.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2211-2015Don't want to check this manually?
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