Recall Z-0230-2022— Beaver Visitec International, Inc.
Class II · Ongoing
Class II FDA medical device recall by Beaver Visitec International, Inc., initiated 2021-10-08. FDA's recall record names no specific 510(k) clearance for this event. Product: bvi CustomEyes Kit-CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component-non-sterile sample for evaluation purposes REF# BVI 58000587. Reason: Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades.
- Recalling firm
- Beaver Visitec International, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-10-08
- Firm location
- Waltham, MA, United States
Product description
bvi CustomEyes Kit-CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component-non-sterile sample for evaluation purposes REF# BVI 58000587
Reason for recall
Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades
Data sourced from openFDA. This site is unofficial and independent of the FDA.