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U.S. Department of Health and Human Services

Enforcement Report - Week of October 30, 2013

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Event Detail

Event ID 65969
Product Type Devices
Status Ongoing
Recalling Firm Synergetics Inc
City O Fallon
State MO
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-30
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution-USA including the states of MO, CO, KY, TN, NC, PA, IL CA, NY, IN, MI, LA, NJ and OH.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Lot number: M222240 Class II One lot of 25 gauge Soft-Tip Disposable Cannulas are co-mingled with 23 gauge cannulas; the product is labeled as 25 gauge cannulas. 48/6-cannula boxes Z-0051-2014