FDA-Device2017-05-03Class II
Stryker SmartLife Large Aseptic Housing (7126-120-000)
Stryker Instruments Div. of Stryker Corporation
Hazard
Stryker Instruments issued a notice of correction for an update to cleaning practices for the Stryker SmartLife Large Aseptic Housings following complaints of deterioration to the housing and the top and bottom housing separating at the weld. Using cleaning practices outside of the HIFU could lead to housing separating at the weld.
Sold states
Domestic: None Foreign: France, Germany
Affected count
302
Manufactured in
4100 E Milham Ave, N/A, Portage, MI, United States
Products
Stryker SmartLife Large Aseptic Housing (7126-120-000)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1886-2017Don't want to check this manually?
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