Recall Z-0051-2014
Synergetics Inc · initiated July 30, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot number: M222240
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.
FDA-determined cause: Labeling Change Control
Action taken
The firm sent recall notification letters to their consignees on 7/30/13.
Details
- Recall number
- Z-0051-2014
- Initiated
- July 30, 2013
- Posted by FDA
- October 22, 2013
- Terminated
- April 7, 2014
- Product code
- HMX – Cannula, Ophthalmic
- 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.
- Recalling firm
- Synergetics Inc, O Fallon, MO