FDAFDA · Food and drugs·Recall number Z-1886-2017
Stryker SmartLife Large Aseptic Housing (7126-120-000)
Published May 3, 2017 · Recall initiated: February 28, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Distributor
- Domestic: None Foreign: France, Germany
- Lot
- Manufacture Start Date for Affected Lots: 18-Mar-2015 Manufacture End Date for Affected Lots: 31-Jan-2017
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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