FDAFDA · Food and drugs·Recall number Z-1538-2014
Joseph Lamelas Atrial Lift System, Model Number MI-ALS-001. A single surgical instrument or tool for retraction of the atrial wall tissue in cardiac surgery.
Published May 14, 2014 · Recall initiated: March 19, 2014
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
The support arm attached with an adhesive to the body of the blade is detaching while attempting to engage the visor component.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biorep Technologies
- Distributor
- US Distribution to a distributor in MN.
- Lot
- Lot numbers: 166934413 (expires 2016/12/10), and 166903414 (expires 2017/02/03).
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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