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U.S. Department of Health and Human Services

Enforcement Report - Week of October 30, 2013

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Product Detail

Product Description 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.
Recall Number Z-0051-2014
Classification Class II
Code Info Lot number: M222240
Product Distributed Qty 48/6-cannula boxes
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.

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 Letter
Distribution Pattern Nationwide Distribution-USA including the states of MO, CO, KY, TN, NC, PA, IL CA, NY, IN, MI, LA, NJ and OH.