Reported May 14, 2014 · Terminated
Joseph Lamelas Atrial Lift System, Model Number MI-ALS-001. A single surgical instrument or tool for retraction of the…
Biorep Technologies
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biorep Technologies · 3225 Nw 112th St · Miami, FL · 33167-3310
Is this the product you have?
- 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.
- Lot codes and dates
- Lot numbers
166934413 (expires 2016/12/10)and 166903414 (expires 2017/02/03)
- Lot numbers
- Amount recalled
- 80 boxes (480 units)
Where it was sold
Why it was recalled
The support arm attached with an adhesive to the body of the blade is detaching while attempting to engage the visor component.
This product could cause temporary or reversible health problems — stop using it.
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