FDAOctober 26, 2015device
MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed to treat female stress urinary incontinence.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The lot number on the outer carton label did not match the lot number printed on the tray label or identification labels inside the box. The identification labels inside the box are placed on medical records and other documents associated with the procedure. Use of incorrectly identified labels may prevent direct traceability of the implanted unit in the future.
What to do
FDA enforcement status: Terminated
Brands named
astora
Recall history
No related federal recalls on record for this brand yet.
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