Beaver Visitec International, Inc. is recalling approximately 3,000 BVI Visitec Irrigation Handles because the packaging labels and individual pouches are missing required manufacturing and expiration dates. These handles are medical devices designed to be used with a cannula for irrigating the eye during surgical procedures. Without an expiration date, healthcare providers cannot ensure the device's sterility or structural integrity at the time of use, which may lead to patient complications. Consumers and healthcare facilities should identify affected units by checking their catalog and lot numbers immediately.
The absence of an expiration date prevents users from knowing if the device is still sterile or safe to use, potentially leading to the use of degraded or non-sterile equipment during delicate eye surgeries.
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If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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