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.
FDA Recall Z-0051-2014 · Posted 2013-10-22
Advertisement
Recalling FirmSynergetics Inc
Recall StatusTerminated
Product CodeHMX
Date Initiated2013-07-30
Date Terminated2014-04-07
Product Quantity48/6-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.
Firm Action
The firm sent recall notification letters to their consignees on 7/30/13.
Root Cause
Labeling Change Control
Distribution Pattern
Nationwide Distribution-USA including the states of MO, CO, KY, TN, NC, PA, IL CA, NY, IN, MI, LA, NJ and OH.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement