MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed to treat female stress urinary incontinence.
FDA Recall Z-0279-2016 · Posted 2015-11-16
Advertisement
Recalling FirmAstora
Recall StatusTerminated
Product CodePAH
Date Initiated2015-10-26
Date Terminated2016-03-09
Product Quantity52
Reason for Recall
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.
Firm Action
Consignees were hand delivered by sales representatives a Astora Women's Health "Urgent Recall Notice". The letter was addressed to Physician, Health Care Professional, Nurse & Risk Manager. The letter described the problem and the product involved in the recall. Consignees were advised to check their inventory and return all affected product, notify those that might be affected and to complete and return the Acknowledgement Form. For questions contact ASTORA Women's Health Customer Service at 1-844-879-0787.
Root Cause
Labeling mix-ups
Distribution Pattern
Distributed in the states of AZ, CA, DE, IL, KS, NE, NJ, NY, OH, PA, TX
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement