Recall Z-0051-2014— Synergetics Inc
Class II · Terminated
Class II FDA medical device recall by Synergetics Inc, initiated 2013-07-30, terminated 2014-04-07. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Synergetics Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-07-30
- Terminated
- 2014-04-07
- Firm location
- O Fallon, MO, United States
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.