Synergetics 25 Gauge Soft Tip Cannula Recall Due to Gauge Mislabeling
Synergetics Inc is recalling 25 gauge Soft Tip Cannulas because some units are co-mingled with 23 gauge cannulas but labeled as 25 gauge.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device mislabeling hazard where the incorrect gauge could be used in surgery, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.
Plain-English summary
Synergetics Inc is recalling one lot of 25 gauge Soft Tip Cannulas, catalog number 30.08.25. The product is a single-use 25 gauge cannula used in vitreoretinal surgery, packaged in boxes of 6 units. The recall involves 48 boxes, totaling 288 individual cannulas.
The recall is being issued because one lot of the 25 gauge cannulas is co-mingled with 23 gauge cannulas, yet the product is labeled as 25 gauge. This mislabeling could lead to the use of the incorrect gauge during surgical procedures. The affected lot number is M222240.
The product was distributed nationwide in the United States, including the states of Missouri, Colorado, Kentucky, Tennessee, North Carolina, Pennsylvania, Illinois, California, New York, Indiana, Michigan, Louisiana, New Jersey, and Ohio. Healthcare facilities and consumers should stop using the affected product and contact Synergetics Inc for further instructions.
The recalled product
- 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.
- Manufacturer
- Synergetics Inc
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot number: M222240
Distribution
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