Device 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.
Z-0051-2014
Product summary
- Firm
- Synergetics Inc
- Event
- Event 65969
- Status
- Terminated
- Classification
- Class II
- Quantity
- 48/6-cannula boxes
- Official record key
device-enforcement:Z-0051-2014
Official wording
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.
Code information: Lot number: M222240
Distribution pattern: Nationwide Distribution-USA including the states of MO, CO, KY, TN, NC, PA, IL CA, NY, IN, MI, LA, NJ and OH.
Derived failure modes
-
Unknown
One lot of 25 gauge Soft-Tip Disposable Cannulas are co-mingled with 23 gauge cannulas; the product is labeled as 25 gauge cannulas.