Class 2 Device Recall Synergetics 25 gauge Soft Tip Cannula

• Date Initiated by Firm: July 30, 2013
• Date Posted: October 22, 2013
• Recall Status: Terminated on April 07, 2014
• Recall Number: Z-0051-2014
• Recall Event ID: 65969
• Product Classification: Cannula, ophthalmic - Product Code HMX
• Product: Synergetics 25 gauge Soft Tip Cannula, packaged in 6 units per box. Catalog number: 30.08.25. Single-use 25 gauge cannula used in vitreoretinal surgery.
• Code Information: Lot number: M222240
• FEI Number: 1000119053
• Recalling Firm/ Manufacturer: Synergetics Inc; 3845 Corporate Centre Dr; O Fallon MO 63368-8678
• For Additional Information Contact: 314-939-5100
• Manufacturer Reason for Recall: One lot of 25 gauge Soft-Tip Disposable Cannulas are co-mingled with 23 gauge cannulas; the product is labeled as 25 gauge cannulas.
• FDA Determined Cause: Labeling Change Control
• Action: The firm sent recall notification letters to their consignees on 7/30/13.
• Quantity in Commerce: 48/6-cannula boxes
• Distribution: Nationwide Distribution-USA including the states of MO, CO, KY, TN, NC, PA, IL CA, NY, IN, MI, LA, NJ and OH.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.