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U.S. Department of Health and Human Services

Class 2 Device Recall Synergetics 25 gauge Soft Tip Cannula

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  Class 2 Device Recall Synergetics 25 gauge Soft Tip Cannula see related information
Date Initiated by Firm July 30, 2013
Date Posted October 22, 2013
Recall Status1 Terminated 3 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
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 2		 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.
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