Recall Z-0051-2014 ยท HMX Cannula, Ophthalmic
Synergetics Inc
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.
| Date | Oct 22, 2013 (initiated Jul 30, 2013) |
| Status | Terminated |
| Reason | One lot of 25 gauge Soft-Tip Disposable Cannulas are co-mingled with 23 gauge cannulas; the product is labeled as 25 gauge cannulas. |
| Root cause | Labeling Change Control |
| Action | The firm sent recall notification letters to their consignees on 7/30/13. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.