Stryker SmartLife Large Aseptic Housing recall
Stryker SmartLife Large Aseptic Housing (7126-120-000)
Why was Stryker SmartLife Large Aseptic Housing recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Manufacture Start Date for Affected Lots: 18-Mar-2015 Manufacture End Date for Affected Lots: 31-Jan-2017
- Product
- Stryker SmartLife Large Aseptic Housing (7126-120-000)
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Quantity
- 302
- Distribution
- Domestic: None Foreign: France, Germany
- Recall date
- May 3, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)