Beaver Visitec Soft Tip Cannula Recall for Missing Protective Sheath
Beaver Visitec is recalling specific lots of Soft Tip Cannulas because a missing protective sheath may cause the silicone tip to break or detach during eye procedures.
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 defect that poses a risk of injury if the tip detaches during a procedure, but the source text does not report any actual injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Beaver Visitec is recalling 3,430 units of BVI Visitec Soft Tip Cannula, 0.8MM .50 x 33mm (25G x 1.3 in). The affected lots are 60047S4, 60060S9, and 600623S. These medical devices are intended to irrigate and/or aspirate ophthalmic solutions and liquids in or out of the eye, and to remove materials during retinal or subretinal procedures.
The recall was initiated because certain lots are missing a protective sheath component over the silicone tip. This defect may result in the silicone tip breaking or detaching at the metal tube component. If the tip becomes detached during a procedure while in the eye, the fragment will need to be retrieved to mitigate the possibility of injury.
The affected products were distributed worldwide, including nationwide in the United States to the states of AR, AZ, CA, CO, FL, GA, LA, MD, MO, NC, NE, NJ, NY, OH, OK, TX, UT, VA, and WA, as well as to Mexico and Peru. Healthcare providers and facilities should stop using the affected lots and contact Beaver Visitec for instructions on retrieval or replacement.
The recalled product
- Product
- BVI Visitec Soft Tip Cannula, 0.8MM .50 x 33mm (25G x 1.3 in). The BVI Soft Tip Cannula is intended to irrigate and/or aspirate ophthalmic solutions and liquids in or out of the eye, and remove materials where appropriate (e.g. retinal, subretinal procedures).
- Manufacturer
- Beaver Visitec
- Affected units
- 3,430
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 (3)
- Lots 60047S4
- 60060S9
- 600623S
Distribution
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