FDA-Device2014-05-14Class II
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.
Biorep Technologies
Hazard
The support arm attached with an adhesive to the body of the blade is detaching while attempting to engage the visor component.
Sold states
US Distribution to a distributor in MN.
Affected count
80 boxes (480 units)
Manufactured in
3225 Nw 112th St, N/A, Miami, FL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1538-2014Don't want to check this manually?
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